ipm 12/iPM 10/iPM 8 ipm 7/iPM 6/iPM 5 Patient Monitor Service Manual

Transcription

1 ipm 12/iPM 10/iPM 8 ipm 7/iPM 6/iPM 5 Patient Monitor Service Manual

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3 Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden. Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.,, and are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners. Contents of this manual are subject to changes without prior notice. Revision History This manual has a revision number. This revision number changes whenever the manual is updated due to software or technical specification change. Contents of this manual are subject to change without prior notice. Revision number: 1.0 Release time: February Shenzhen Mindray Bio-Medical Electronics Co., Ltd. All rights reserved. I

4 Preface Manual Purpose This manual provides detailed information about the assembling, dissembling, testing and troubleshooting of the equipment to support effective troubleshooting and repair. It is not intended to be a comprehensive, in-depth explanation of the product architecture or technical implementation. Observance of the manual is a prerequisite for proper equipment maintenance and prevents equipment damage and personnel injury. This manual is based on the maximum configuration; Therefore, some contents may not apply to your monitor. If you have any question, please contact our Customer Service Department. Intended Audience This manual is for biomedical engineers, authorized technicians or service representatives responsible for troubleshooting, repairing and maintaining the patient monitors. Abbreviations Abbreviations used in this manual are: MPM SMR CMS PCB multi-parameter module satellite module rack central monitoring system printed circuit board Passwords A password may be required to access different modes within the monitor. The passwords are listed below: User maintenance: (User adjustable) Factory maintenance: Demo mode: 2088 Configuration mode: (User adjustable) II

5 Contents 1 Safety Safety Information Dangers Warnings CAUTION NOTE Equipment Symbols Theory of Operation The Basics System Connections Installation Support Connectors for Peripheral Devices Main Unit Front Housing Assembly Main Board Keypad Alarm Lamp Board Touchscreen and Touchscreen Control Board Wi-Fi Module Rear Housing Assembly AC/DC Power Board Power Management Board Interface Board Battery Interface Board Recorder Multi-parameter Board SpO2 Board Parameter Connector Board Modules Module Converter Converter IBP + C.O. Module CO2 Module AG Module Unpacking and Installation Unpacking the Equipment Preparation for Installation Preparation for Installation Site Electrical Requirements

6 3.2.3 Monitor Installation Preparation for Power on Hardware and Software Upgrade Hardware Upgrade Upgrade Package Hardware Upgrade Method Software Upgrade Installing Mindray Patient Monitor Software Upgrade Tool Software Upgrade Procedure Testing and Maintenance Introduction Test Equipment Test Report Preventative Maintenance Recommended Frequency Visual Inspection Power-on Test Module Performance Tests ECG Tests and Calibration Resp Test SpO2 Test NIBP Test Temp Test IBP Test and Calibration C.O. Test Mainstream CO2 Tests Sidestream and Microstream CO2 Tests AG Tests and Calibration Nurse Call Reply Performance Test Analog Output Performance Test Electric Safety Tests Touchscreen Calibration Recorder Check Battery Check Factory Maintenance Accessing Factory Maintenance Menu Drawing Waves Recorder Software version Monitor information recording Troubleshooting Introduction Part Replacement

7 6.3 Checking Patient Monitor Status Checking Software Version Checking Technical Alarms Troubleshooting Guide Power On/Off Failure Display Failures Alarm Lamp Failures Button and Knob Failures Sound Failures Battery Failures Recorder Failures Output Interface Failure Data Storage Failure Wired Network Related Problems Wi-Fi Related Problems Module Failures Software Upgrade Problems Technical Alarm Messages Disassembly and Repair Tools Required Preparations for Disassembly Disassembling the Main Unit Separating the Front and Rear Half of the Monitor Disassembling Parameter Modules Removing the Parameter Connector Panel Assembly Removing the SpO2 Board and Parameter Board Removing Pump and Valve Removing the Recorder (Optional) Removing Battery Interface Board and Power Board (ipm 5/iPM 6/iPM 8/iPM 10) Removing the Battery Interface Board and Power Board (ipm 7/iPM 12) Removing the Power Management Board Removing the Interface Board (ipm 5/iPM 8) Removing the Interface Board (ipm 6/iPM 7/iPM 10/iPM 12) Disassembling the Front Housing Assembly Removing Touchscreen Control Board (Optional) Removing the Wi-Fi Module (Optional) Removing SD Card (Optional) Removing the Main Control Board Removing the Touchscreen (Optional) Disassembling the Screen Removing the Keypad Removing the Encoder Removing the Alarm Lamp Board Disassembling Modules Removing the External Converter Board

8 7.5.2 Separating the Front and Rear Housing of Modules Removing the External Module Interface Board Removing M03B Module Removing Sidestream CO2 Module Removing Microstream CO2 Module Removing AG Module Parts Introduction ipm 8/iPM Main Unit Front Housing Subassembly (Touchscreen) Front Housing Assembly (Nakescreen) Rear Housing Assembly Multi-parameter Assembly Battery Compartment Assembly NIBP Pump and Valve Kit IBP_C.O. Module Assembly IBP_C.O._Sidestream CO2 Module Assembly/ IBP_Sidestream CO2 Module Assembly IBP_C.O._Microstream CO2 Module Assembly/IBP_Microstream CO2 Module Assembly IBP_C.O._Mainstream CO2 Module Assembly/IBP_Mainstream CO2 Module Assembly ipm 10/iPM Main Unit Front Housing Subassembly (Touchscreen) Front Housing Assembly (Nakescreen) Rear Housing Assembly Battery Compartment Assembly Multi-parameter Assembly NIBP Pump and Valve Kit IBP_C.O. Module Assembly IBP_C.O._Sidestream CO2 Module Assembly/IBP_Sidestream CO2 Module Assembly IBP_C.O._Microstream CO2 Module Assembly/IBP_Microstream CO2 Module Assembly IBP_C.O._Mainstream CO2 Module Assembly/IBP_Mainstream CO2 Module Assembly IBP_C.O._AG Module Assembly/ IBP_AG Module Assembly ipm 12/iPM Main Unit Front Housing Subassembly (Touchscreen) Front Housing Assembly (Nakescreen) Rear Housing Assembly Battery Compartment Assembly Multi-parameter Assembly NIBP Pump and Valve Kit IBP_C.O. Module Assembly IBP_C.O._Sidestream CO2 Module Assembly/IBP_Sidestream CO2 Module Assembly IBP_C.O._Microstream CO2 Module Assembly/IBP_Microstream CO2 Module Assembly IBP_C.O._Mainstream CO2 Module Assembly/IBP_Mainstream CO2 Module Assembly

9 IBP_C.O._AG Module Assembly/IBP_AG Module Assembly A Electrical Safety Inspection... A-1 A.1 Power Cord Plug... A-1 A.2 Device Enclosure and Accessories... A-1 A.2.1 Visual Inspection... A-1 A.2.2 Contextual Inspection... A-1 A.3 Device Labeling... A-2 A.4 Protective Earth Resistance... A-2 A.5 Earth Leakage Test... A-3 A.6 Patient Leakage Current... A-4 A.7 Mains on Applied Part Leakage... A-6 A.8 Patient Auxiliary Current... A-8 A.9 Scheduled Electrical Safety Inspection... A-9 A.10 Electrical Safety Inspection after Repair... A-10 5

10 FOR YOUR NOTES 6

11 1 Safety 1.1 Safety Information DANGER Indicates an imminent hazard that, if not avoided, will result in death or serious injury. WARNING Indicates a potential hazard or unsafe practice that, if not avoided, will result in death or serious injury. CAUTION Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. NOTE Provides application tips or other useful information to ensure that you get the most from your product. 1-1

12 1.1.1 Dangers There are no dangers that refer to the product in general. Specific Danger statements may be given in the respective sections of this manual Warnings WARNING All installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel. There is high voltage inside the equipment. Never disassemble the equipment before it is disconnected from the AC power source or the battery. When you disassemble/reassemble a parameter module, a patient leakage current test must be performed before it is used again for monitoring. The equipment must be connected to a properly installed power outlet with protective earth contacts only. If the installation does not provide for a protective earth conductor, disconnect it from the power line and operate it on battery power, if possible. Disposal of the packaging material should observe the applicable waste control regulations. and keeping it out of children s reach CAUTION CAUTION Make sure that no electromagnetic radiation interferes with the performance of the equipment when preparing to carry out performance tests. Mobile phone, X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation. Before connecting the receiver to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit s label or in this manual. Protect the equipment from damage caused by drop, impact, strong vibration or other mechanical force during servicing NOTE NOTE Refer to Operator s Manual for detailed operation and other information. 1-2

13 1.2 Equipment Symbols Caution, consult accompanying documents Power ON/OFF (for a part of the equipment) Alternating current Battery indicator ALARM PAUSED AUDIO PAUSED Graphical recorder Freeze/unfreeze waveforms Main menu NIBP start/stop key Alternating/Direct current Inserted direction Direct current Equipotentiality VGA output USB connector Network connector Gas outlet Input/output DATE OF MANUAFACTURE Serial number AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Electrostatic sensitive devices DEFIBRILLATION-PROOF TYPE CF DEFIBRILLATION-PROOF TYPE BF APPLIED PART APPLIED PART The product bears CE mark indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfils the essential requirements of Annex I of this directive. The following definition of the WEEE label applies to EU member states only. This symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased it. * For system products, this label may be attached to the main unit only. NOTE Some symbols may not appear on your equipment. 1-3

14 FOR YOUR NOTES 1-4

15 2 Theory of Operation 2.1 The Basics This patient monitor is designed to monitor a fixed set of physiological parameters including ECG, respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG). The patient monitor also: Provides audible and visual alarm indications in case of patient or equipment problems. Enables displaying, reviewing, storing and transferring of real-time data and wave. Incorporates multiple input devices such as buttons, knob, and touchscreen. Enables program upgrade over the network. Integrates the information of other devices, which include but are not restricted to defibrillator. Signal Output Defibrillation Main unit module CMS Local Display Analog Signal Output ipm-t Wi-Fi LAN Remote Monitor Printer IABP 2-1

16 The above figure shows a system consists of the ipm patient monitor and its peripheral devices. The ipm patient monitor: Can be used for monitoring the physiological parameters, giving alarms and reviewing patient data, etc. Supports recorder. Supports nurse call signal, synchronization defibrillation signal, and analog output signal. Supports Wi-Fi module, wired network, remote view, and communication with the HyperVisor Central Monitoring System. Supports a secondary display. Supports AC power source and battery power source (ipm 8/iPM 5 patient monitors additionally supports DC power source). Supports clinical data acquisition, which has two ways: by SD card and by USB drive. The system software should support data output function, for SD card is a built-in device. 2.2 System Connections Installation Support The patient monitor can be mounted on a wall bracket or on a trolley support. The wall bracket or trolley support can be ordered optionally. Each type of mounting bracket is delivered with a complete set of mounting hardware and instructions. Refer to the documentation delivered with the mounting hardware for instructions on assembling mounts. CAUTION Use mounting brackets we supply or approve. If other compatible mounting bracket is used, be sure it can be safely used on the patient monitor. The mounting bracket should be installed by our qualified service personnel, or engineers who have adequate knowledge on it. If other mounting solution is used, the installation personnel and the customer should verify if it can be safely used on the patient monitor, and the customer assume the responsibility for any risk resulting from that. Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage. 2-2

17 2.2.2 Connectors for Peripheral Devices On the back of the patient monitor you can find all connectors for peripheral devices. ipm 6/7/10/12 Rear View 1. AC power input: used to connect an AC power source (100 to 240 VAC, 50/60 Hz). 2. Equipotential terminal: used to connect the equipotential terminal of other equipments, eliminating potential difference between different pieces of equipment. 3. Parameter Module slot: used to connect the parameter module. 4. General USB Connector: used to connect any USB-compatible peripheral device. 5. Multifunctional connector: used to output analog signals and defibrillator synchronization signals. 6. Network Connector: an RJ45 connector, used to connect an Ethernet network or a PC. 7. VGA Connector: used to connect a secondary display. 2-3

18 ipm 5/8 Rear View 1. Equipotential terminal: used to connect the equipotential terminal of other equipments, eliminating potential difference between different pieces of equipment. 2. AC power input: used to connect an AC power source (100 to 240 VAC, 50/60 Hz). 3. Parameter Module slot: used to connect the parameter module. 4. Multifunctional connector: used to output analog signals and defibrillator synchronization signals. 5. DC power input 6. General USB Connector: used to connect any USB-compatible peripheral device. 7. Network Connector: an RJ45 connector, used to connect an Ethernet network or a PC. 8. VGA Connector: used to connect a secondary display. 2-4

19 2.3 Main Unit The main unit of the patient monitor consists of two parts: Front housing assembly: main board, keypad board assembly (knob), display, touchscreen, alarm lamp board, power switch, and indicator board. Rear housing assembly: power board (AC/DC), power management board, battery pad, interface board, recorder, speaker, and multi-parameter module which includes three types of SpO2 stacking board. The following figure shows the main unit architecture of the patient monitor. Speaker Interface Board Power Board Battery Interface Board Power Management Board Multi-parameter Board Parameter Connector Panel Recorder SpO 2 Board Alarm Lamp Board Main Board Display Keypad Board Antenna Touchscr een Touchscreen Control Board Wi-Fi 2-5

20 2.4 Front Housing Assembly Screws fixing the front and rear housing Alarm lamp board Main board Wi-Fi module Touchscreen control board Keypad Lock hatch Main Board The main board is the control center of the system. It provides communication, display, and data storage functions, including: Display drive and backlight control Wired and wireless network Data Storage Printing Serial port communication Connection with touchscreen control board Audio drive EEPROM drive USB drive Keypad The keypad scans and detects the input of keys and knobs, integrates the power on/off key, and connects AC and battery indicators. 2-6

21 2.4.3 Alarm Lamp Board The alarm lamp board is located at the top of front housing. It has two-color indicators, red and yellow. The alarm lamp board directly connects the main board through a cable. It is controlled directly by the main board Touchscreen and Touchscreen Control Board The touchscreen control board drives the touchscreen and implements communication with the patient monitor Wi-Fi Module The Wi-Fi module enables the patient monitor to connect to g/n wireless network. 2.5 Rear Housing Assembly Multi-parameter assembly Pump and valve assembly Recorder assembly Parameter panel assembly Interface Board Main bracket assembly Power management board The rear housing assembly consists of the parameter panel assembly, multi-parameter assembly, pump and valve assembly, recorder assembly, main bracket assembly (including the battery compartment and battery interface board), power management board, and interface board. 2-7

22 2.5.1 AC/DC Power Board The AC/DC power board transforms the input AC into DC power, which is the power source for all voltages in the patient monitor Power Management Board The power management board mainly performs DC/DC conversion, power management, and transmission of external connector signals: DC/DC conversion: outputs 12 V and 5 V DC power Power on/off control Charge/Discharge control Signal transmission Interface Board The interface board supports the USB ports, network ports, multifunctional ports. and VGA ports Battery Interface Board The battery interface board introduces the battery power to the internal system Recorder The recorder receives data from the main board and sends them to the thermal printhead for printing Multi-parameter Board The multi-parameter board provides the following functions: Supports 2-channel 3-/5-lead ECG monitoring (and 12-lead in future), and I/II lead Resp monitoring Provides power for and communicates with Mindray/Nellcor/Masimo SpO2 board Supports 2-channel Temp monitoring Supports 2-channel IBP monitoring Supports NIBP monitoring Processes all algorithms and communicates with the main board via UART Realizes analog output (four channels, one for ECG, two for IBP, and the other for Defib sync output) Isolates the parameter modules from the earth Isolates ECG from other parameters 2-8

23 2.5.7 SpO 2 Board The multi-parameter module supports the independently developed Mindray SpO2 board, which provides SpO2 measurement as good as other boards but with smaller size and lower consumption. It is also compatible with Nellcor NELL-1 SpO2 board and Masimo MS-2013 SpO2 board. SpO2 board is used to collect SpO2 signals transmitted by the multi-parameter module and process SpO2 algorithms Parameter Connector Board The parameter connector board transmits the ECG signal, Temp signal, SpO2 signal, and IBP signals collected through cables to the multi-parameter board. 2.6 Modules The patient monitor can carry multiple parameter modules, which include IBP/C.O., CO2, and AG modules. The detailed module configuration is listed below: IBP module CO2 Module IBP + C.O. Module IBP + C.O. + CO2 (Mindray Sidestream CO2/Mainstream CO2/Microstream CO2) module IBP + C.O. + AG (w O2/wo O2) module Converter Board External Converter Board Module Converter The module converter performs signal conversion function. 2-9

24 2.6.2 Converter The converter performs the following functions: Converting 12 V to 5 V DC power Converting 232 level to TTL level Detecting and identifying the modules IBP + C.O. Module The IBP/C.O. module supports C.O. and 2-channel measurement of IBP. The module consists of an amplification circuit, AD converter, CPU circuit and power isolation circuit CO 2 Module The patient monitor supports the following CO2 modules: M02C Sidestream module Capnostat Mainstream CO2 module Ordion Microstream CO2 module AG Module There are two configurations for the 2.5G Artema AG module: with O2 and without O

25 3 Unpacking and Installation 3.1 Unpacking the Equipment Open the package and take out the packing list. Check that all the articles included in the packing list are available and the quantity and specification are correct. Make sure that: All the optional parts purchased by the customer shall also be checked. Notify the supplier if provided components are not correct as compared to the packing list. In case of damage during transportation, keep the packing material and notify the supplier immediately. Keep the packing material till new equipment is accepted. The following pictures show the patient monitor and accessory packing. Accessories Operator's Manual and Packing List Main Unit Main unit packing Accessory packing 3-1

26 3.2 Preparation for Installation Preparation for Installation Site 1. Ensure that the site meets all safety, environmental and power requirements. 2. Check that required power sockets are available. 3. Check that a network connector is available if the patient monitor needs to be connected to network. Environmental Requirements To avoid explosion hazard, do not use the equipment in the presence of flammable anesthetics, vapors or liquids. The environment where the patient monitor will be used should be reasonably free from vibration, dust and corrosive substances. If these conditions are not met, the system may not function normally. The environmental specification is as follows: Main Unit (ipm 5/8) Item Temperature ( C) Relative humidity (noncondensing) Altitude (kpa) Operating environment 0 to 40 15% to 95% 57.0 to Storage environment -30 to 70 10% to 95% 16.0 to Main Unit (ipm 6/7/10/12) Item Temperature ( C) Relative humidity (noncondensing) Altitude (kpa) Operating environment 0 to 40 15% to 95% 57.0 to Storage environment -20 to 60 10% to 95% 16.0 to Mainstream CO2 module Item Temperature ( C) Relative humidity (noncondensing) Altitude (kpa) Operating environment 0 to 40 15% to 90% 57.0 to Storage environment -20 to 60 10% to 90% 53.3 to Sidestream CO2 module Item Temperature ( C) Relative humidity (noncondensing) Altitude (kpa) Operating environment 5 to 40 15% to 95% 57.3 to Storage environment -20 to 60 10% to 95% 57.3 to Microstream CO2 module Item Temperature ( C) Relative humidity (noncondensing) Altitude (kpa) Operating environment 0 to 40 15% to 95% 57.3 to Storage environment -20 to 60 10% to 95% 57.3 to NOTE The environmental specifications of unspecified parameters are the same as those of ipm 6/7/10/12 main unit. 3-2

27 3.2.2 Electrical Requirements Check cables and power cords. Make sure that: 1. Check that the system cables, power cords, and power plugs are not damaged, and pins are not loose. In case of any damage, remove it from use. 2. The insulation of patient cables and leadwires is not damaged, and connectors are not loose. WARNING Only power sockets with protective grounding can be used. Line voltage Current Frequency 100 to 240 V AC 1.1 to 0.5 A 50/60 Hz Monitor Installation Refer to GCX Adapter Installation Guide (PN: ), Ambulance Mounting Installation Guide (ipm ) (PN: ), ipm 8 Hook Assembly Installation Guide (PN: ) Preparation for Power on 1. Before you start to make measurements, check the patient monitor for any mechanical damage and make sure that all external cables, plug-ins and accessories are properly connected. 2. Plug the power cord into the AC power source. If you run the patient monitor on battery power, ensure that the battery is sufficiently charged. 3. Press the power on/off switch on the monitor's front. 3-3

28 FOR YOUR NOTES 3-4

29 4 Hardware and Software Upgrade 4.1 Hardware Upgrade ipm patient monitors supports upgrade of the following functions: 12-lead ECG measurement (only for monitors with Mindray ECG algorithm); IBP measurement; C.O. measurement; CO2 measurement; AG measurement; O2 measurement; Analog output and Sync Defib; Wireless network; Recorder; and, Hook Upgrade Package Upgrade Monitor config. Description of upgrade package PN of upgrade package package before upgrade / IBP_C.O. module kit / IBP_C.O._Sidestream CO2 module kit / IBP_C.O._Microstream CO2 module kit (English) / IBP_C.O._Microstream CO2 module kit (Chinese) / IBP_C.O._Mainstream CO2 module kit / IBP_Sidestream CO2 module kit / IBP_Microstream CO2 module kit (English) / IBP_Microstream CO2 module kit (Chinese) Parameter / IBP_Mainstream CO2 module kit module / Sidestream CO2 module kit / Microstream CO2 module kit (English) / Microstream CO2 module kit (Chinese) / Mainstream CO2 module kit / IBP_C.O._AG module kit / IBP_AG module kit / IBP module kit / IBP_C.O._AG (w O2) module kit / IBP_AG (w O2) module kit Lead ECG 3/5-Lead ECG ipm multi-parameter board PCBA (complete) Analog/Sync Defib output / ipm multi-parameter board PCBA (5-Lead, complete)

30 Upgrade Monitor config. Description of upgrade package PN of upgrade package package before upgrade Wireless / ipm 12 Wi-Fi module kit network / ipm 8/10 Wi-Fi module kit Recorder / ipm recorder upgrade kit Hook / ipm 10/12 hook assembly kit / ipm 8 hook assembly kit Note: measurement accessories are not included in the above upgrade packages Hardware Upgrade Method Upgrading the Parameter Modules The external parameter modules are ready for use once properly installed into the module slot on the back of the patient monitor Upgrading 12-Lead ECG Function Replace the original parameter board with the multi-parameter board with 12-lead ECG monitoring function as described in Disassembling Parameter Modules Upgrading Analog/Sync Defib Output Function Replace the original parameter board with the multi-parameter board with analog/sync Defib output function as described in Disassembling Parameter Modules Upgrading Wireless Network Function 1. Install the Wi-Fi module onto the main board and then connect the Wi-Fi antennas as described in Removing the Wi-Fi Module (Optional). 2. Select [Main Menu] [Maintenance >> ] [User Maintenance >> ] enter the required password [Network Setup >>], and then set the [Network Type] to [WLAN]. Correctly set the patient monitor and connect to a nearby wireless network as described in Network Connection in ipm 12/iPM 10/iPM 8/iPM 7/iPM 6/iPM 5 Patient Monitor Operator s Manual to confirm that the Wi-Fi function is available on the patient monitor Upgrading Recorder Function 1. Install a recorder onto the patient monitor as described in Removing the Recorder (Optional). 2. Install paper into the recorder and perform printing task as described in Recorder in ipm 12/iPM 10/iPM 8/iPM 7/iPM 6/iPM 5 Patient Monitor Operator s Manual to confirm that the recorder works well on the patient monitor. 4-2

31 Installing Hooks For ipm 6/7/10/12 Patient Monitors Fix the two hooks on to the handle with four M3 10 screws (torque force value: 4 to 6 kgf.cm) with the hook facing the ground, as shown below: Hook Screw, Pan head with washer, Phillips M3 10 For ipm 5/8 Patient Monitors 1. Remove the handle shield, and install the hook to the handle as shown below. Then insert the positioning pin into the corresponding hole on the hook assembly. Fix the hook with two M3 6 screws (torque force: 4 to 6 kgf.cm). 2. Install and fix the other hook onto the patient monitor as described. Screw, Pan head w/washer, Phillips M

32 4.2 Software Upgrade You can upgrade system software and module software by installing and running the Mindray Patient Monitor Software Upgrade Tool (PN: ) on a PC with Windows operating system. Connect the monitor to be upgraded and a PC running the upgrade tool to the same network, or directly connect the monitor and the PC via a crossover network cable. Then configure the IP address of the PC. You can upgrade the following software: No. Type PN Description / System software package (language library: Simplified Chinese) 1. System software package / System software package (language library: Traditional Chinese) Nios software for module Nios online upgrade program converter MO software for power management board DSP (BF512) software for M51A V2.0 module DSP (Mortara algorithm) software for M51A V2.0 module Module software Software for 9008 SpO2 module STM32 software for M02C module 8. M03B Software for M03B module (download online) Note: No specific sequence is required for the upgrading of above software. For detailed information, please refer to Software Upgrade Procedure Installing Mindray Patient Monitor Software Upgrade Tool 1. Find the installation program and double click it to start installation. 2. Select [ 英语 ]. 4-4

33 3. Click [ 确定 ] and the following screen is displayed. Click [Next] to go to the next step. 4. Enter User Name, Company name, and Serial Number " ". Then click [Next]. 5. Specify the destination folder for installing this program. Then select [Next]. 4-5

34 6. Select Program Folder. Then select [Next]. 7. Click [Finish] to complete installation Software Upgrade Procedure Before software upgrade, select [Main Menu] [Maintenance >> ] [Factory Maintenance >> ] enter the required password [Software Version] to check the current software version, as described in Software version. 1. Connect the monitor to be upgraded and a PC running the upgrade tool to the same network, or directly connect the monitor and the PC via a network cable (a crossover network cable is recommended). 2. Set the IP address of the PC to " XX" and subnet mask to " ". 4-6

35 3. Run Mindray Patient Monitor Software Upgrade Tool on the PC and set Machine to [ipm 8/10/12]. 4. On the Mindray Patient Monitor Software Upgrade Tool screen, select [Select Package] and then the packages you want to upgrade. Then select [Start]. 5. Turn on the patient monitor to be upgrade. Press and hold "Silence" and "Main Menu" buttons for 2 to 3 seconds, the patient monitor enters upgrade mode and starts software upgrade automatically, and corresponding prompt messages are displayed on both the patient monitor and PC. When software upgrade is finished, restart the patient monitor and check if the software is correctly upgrade. For details of software upgrade, please refer to help and instructions for use of Mindray Patient Monitor Software Upgrade Tool. CAUTION Disconnect the equipment from the patient and make sure the important data are saved before upgrade. Do not shut down or power off the equipment when upgrading the system software. Otherwise, it may cause the equipment to break down. Software upgrade should be performed by qualified service personnel only. Crossover network cable is recommended when a PC is connected for software upgrade. NOTE Make sure the version of the upgrade package is what you desired. To obtain the latest upgrade package, please contact Mindray Customer Service Department. 4-7

36 FOR YOUR NOTES 4-8

37 5 Testing and Maintenance 5.1 Introduction To ensure the patient monitor always functions normally, qualified service personnel should perform regular inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the patient monitor with recommended test equipments and frequency. The service personnel should perform the testing and maintenance procedures as required and use appropriate test equipments. The testing procedures provided in this chapter are intended to verify that the patient monitor meets the performance specifications. If the patient monitor or a module fails to perform as specified in any test, repairs or replacements must be done to correct the problem. If you have any question, contact our Customer Service Department. CAUTION All tests should be performed by qualified service personnel only. Care should be taken to change the settings in [User Maintenance] and [Factory Maintenance] menus to avoid loss of data. Service personnel should acquaint themselves with the test tools and make sure that test tools and cables are applicable Test Equipment See the following sections Test Report Upon the completion of the tests, the table of preventative maintenance test reports and the table of maintenance test reports in this chapter should be kept properly Preventative Maintenance Below are preventative maintenance tests which need to be performed on the monitor. The recommended frequency of preventative maintenance is at least once per year. See the following sections for detailed maintenance procedures. Visual inspection NIBP test CO2 test and calibration AG test and calibration 5-1

38 5.1.4 Recommended Frequency Check/Maintenance Item Visual inspection Power-on test Frequency 1. When first installed or reinstalled. 1. When first installed or reinstalled. 2. Following any repairs or replacement of any main unit parts. ECG test Resp performance test Performance Test Module calibration SpO2 test NIBP test Pressure check Leakage test TEMP test Performance test IBP test Pressure calibration C.O. test Mainstream CO2 test Leakage test Sidestream and Performance test Microstream CO2 tests Calibration Leakage test AG test Performance test Calibration Nurse call function test Analog output performance test 1. If the user suspects that the measurement is incorrect. 2. Following any repairs or replacement of relevant module. 3. At least once every two years. Note: At least once a year is recommended for NIBP, CO2, and AG. If the user suspects that the nurse call or analog output does not work well. Electric Safety Tests Refer to A Electrical Safety Inspection. 1. Following any repair or replacement. 2. After the monitor drops. 3. At least once every two years. Touchscreen calibration Recorder check Battery check Functionality test Performance test 1. When the touchscreen appears abnormal. 2. After the touchscreen is replaced. Following any repair or replacement of the recorder. 1. When first installed. 2. Whenever a battery is replaced. Once every six months or if the battery run time reduced significantly. 5-2

39 5.2 Visual Inspection Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no obvious signs of damage. Following these guidelines when inspecting the equipment: Carefully inspect the case, display screen, buttons, and knob for obvious signs of damage. Inspect the power cord, wall mount, and accessories for obvious signs of damage. Inspect all external connections for loose connectors, bent pins or frayed cables. Inspect all connectors on the equipment for loose connectors or bent pins. Make sure that safety labels and data plates on the equipment are clearly legible. 5.3 Power-on Test This test is to verify that the patient monitor can power up correctly. The test is passed if the patient monitor starts up by following this procedure: 1. Insert the battery in the battery compartment and connect the patient monitor to the AC mains. The AC mains LED and battery LED light. 2. Press the power on/off switch to switch on the patient monitor. The monitor performs self-test as soon as the monitor is powered on. During the self-test, the alarm lamp turns yellow and red, and then turns off; the monitor gives a beep. This indicates that the visual and audible alarm indicators operate properly. 5.4 Module Performance Tests ECG Tests and Calibration ECG Performance Test Tool required: Fluke Medsim 300B patient simulator recommended 1. Connect the patient simulator with the ECG connector using an ECG cable. 2. Set the patient simulator as follows: ECG sinus shythm, HR = 80 bpm with the amplitude as 1 mv. 3. Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ± 1 bpm. 4. Disconnect each of the leads in turn and observe the corresponding lead off message displayed on the screen. 5. Set the simulator outputs paced signals and set [Paced] to [Yes] on the monitor. Check the pace pulse marks on the monitor screen. 5-3

40 ECG Calibration Tool required: Vernier caliper 1. Select the ECG parameter window or waveform area and set [Filter] to [Diagnostic]. 2. Select [Main Menu] [Maintenance >>]. 3. Select [Calibrate ECG]. A square wave appears on the screen and the message [ECG calibrating] is displayed. 4. Compare the amplitude of the square wave with the wave scale. The difference should be within 5%. 5. After completing the calibration, select [Stop Calibrating ECG]. You can print out the square wave and wave scale and then measure the difference between them if necessary Resp Test Tool required: Fluke Medsim 300B patient simulator recommended 1. Connect the patient simulator to the module using a non ESU-proof cable and set lead II as the respiration lead. 2. Configure the simulator as follows: lead II as the respiration lead, base impedance line as 1500 Ω, data impedance as 0.5 Ω, and respiration rate as 40 rpm. 3. Check the Resp wave is displayed without any distortion and the displayed Resp value is within 40 ± 2 rpm SpO 2 Test Tool required: None 1. Connect SpO2 sensor to the SpO2 connector of the monitor. Set [Patient Cat.] to [Adu] and [PR Source] to [SpO2]. 2. Apply the SpO2 sensor to your ring finger (assume that you stay healthy). 3. Check the Pleth wave and PR reading on the screen and make sure that the displayed SpO2 is within 95% and 100%. 4. Remove the SpO2 sensor from your finger and make sure that an alarm of SpO2 Sensor Off is triggered. NOTE A functional tester cannot be used to assess the accuracy of a pulse oximeter monitor. However, it can be used to demonstrate that a particular pulse oximeter monitor reproduces a calibration curve that has been independently demonstrated to fulfill a particular accuracy specification. 5-4

41 5.4.4 NIBP Test NIBP Leakage Test NOTE Perform NIBP leakage test before any other NIBP concerned test. Tools required: NIBP cuff for adult patient Tubing Cylinder Follow this procedure to perform the leakage test: 1. Set [Patient Cat.] to [Adu]. 2. Connect the NIBP cuff to the NIBP connector on the monitor. 3. Apply the cuff to the cylinder as shown below. Monitor Cylinder Connector for NIBP cuff Air tubing Cuff 4. Select [Main Menu] [Maintenance >> ] [NIBP Leakage Test]. The message [Leakage Testing ] is displayed in the NIBP parameter area. 5. The cuff automatically deflates after 20 s, which means NIBP leakage test is completed. 6. If no message is displayed in the NIBP parameter area, it indicates that the system has no leakage. If the message [NIBP Pneumatic Leak] is displayed, it indicates that the system may have a leakage. In this case, check if all connections are good and the cuff and tubing have no leakage. Perform the test again after making sure all connections are good and the cuff and tubing have no leakage. You can either perform a manual leakage test: 1. Perform steps 1 to 4 in the NIBP Accuracy Test section. 2. Raise the pressure in the rigid vessel to 250 mmhg with the balloon pump. Then, wait for 5 seconds to let the measured values becoming stable. 3. Record the current pressure value, and meanwhile use a time counter to count the time. Then, record the pressure value after 60 s. 4. Compare the two pressure values and make sure the difference should not be greater than 6 mmhg. 5-5

42 NIBP Accuracy Test Tool required: T-shape connector Appropriate tubing Balloon pump Rigid Vessel with volume 500 ± 25 ml Reference manometer (calibrated with accuracy equal to or better than 0.75 mmhg) Follow this procedure to perform the accuracy test: 1. Connect the equipments as shown below. Monitor Connector for NIBP cuff Appropriate tubing Standard sphygmomanome ter Balloon pump Rigid Vessel 2. Before inflation, check that the reading of the manometer is 0. If not, turn off the balloon pump to let the whole airway open to the atmosphere. Turn on the balloon pump after the reading is Select [Main Menu] [Maintenance >> ] [NIBP Accuracy Test]. 4. Check the manometer values and the monitor values. Both should be 0 mmhg. 5. Raise the pressure in the rigid vessel to 50 mmhg with the balloon pump. Then, wait for 10 seconds to let the measured values become stable. 6. Compare the manometer values with the monitor values. The difference between the manometer and displayed values should be ± 3 mmhg. 7. Raise the pressure in the rigid vessel to 200 mmhg with the balloon pump. Then, wait for 10 seconds to let the measured values become stable. Repeat step 6. NOTE You can use an NIBP simulator to replace the balloon pump and the reference manometer to perform the test. You can use an appropriate cylinder and a cuff instead of the rigid vessel. 5-6

43 5.4.5 Temp Test Tool required: Resistance box (with accuracy above 0.1 Ω) 1. Connect the two pins of any Temp connector in the monitor to the two ends of the resistance box using 2 wires. 2. Set the resistance box to Ω (corresponding temperature is 37 C). 3. Verify each Temp channel of the monitor and make sure that the displayed value is within 37 ± 0.1 C. 4. Repeat steps 1 to 3 and verify another temperature channel IBP Test and Calibration IBP Performance Test Tools required: Medsim300B patient simulator, or MPS450, or equivalent equipments IBP adapter cable for test (P/N for Medsim 300B, P/N , for MPS450) 1. Connect the patient simulator through the monitor's IBP connector. 2. Make the patient simulator outputs 0 mmhg to an IBP channel. 3. Select IBP Zero in the IBP setup Menu to make a zero calibration. 4. Set the patient simulator as P (static) = 200 mmhg. 5. The displayed value should be within 200 ± 4 mmhg. 6. If the error is beyond ± 4 mmhg, calibrate the pressure module. If the IBP module was calibrated with a dedicated reusable IBP sensor, check the calibration together with this IBP sensor. 7. Let the patient simulator output 120/80 mmhg ART signal and 120/0 mmhg LV signal to the IBP channel and check that the IBP wave is displayed correctly. 8. Repeat the steps above to calibrate other IBP channels. IBP Pressure Calibration Method 1: Tools required: Medsim300B patient simulator, or MPS450, or equivalent equipments IBP adapter cable for test (P/N for Medsim 300B, P/N , for MPS450) 1. Connect the patient simulator through the monitor's IBP connector. 2. Set the patient simulator to 0 for the desired IBP channel. 3. Select IBP Zero in the IBP setup Menu to make a zero calibration. 4. Set the patient simulator as P (static) = 200 mmhg. 5-7

44 5. Select [Main Menu] [Maintenance >> ] [Cal. IBP Press. >>]. In the [Cal. IBP Press.] menu, set the calibration value to 200 mmhg. 6. Select the [Calibrate] button next to the desired IBP channel to start calibration. 7. If the calibration is completed successfully, the message [Calibration Completed!] will be displayed. Otherwise, a corresponding message will be displayed. Method 2: Tools required: Standard sphygmomanometer Balloon pump Appropriate tubing T-shape connector 1. Connect the 3-way stopcock, the sphygmomanometer and the balloon pump through a T-shape connector, as shown below. Pressure transducer Stopcock Adapter cable for using disposable transducers T-shape connector IBP module Sphygmomanometer 2. Vent the transducer to the atmospheric pressure by turning on the 3-way stopcock to the air. Zero the transducer, and then open the stopcock to the sphygmomanometer. 3. Select [Main Menu] [Maintenance >> ] [Cal. IBP Press. >>]. In the [Cal. IBP Press.] menu, configure the IBP calibration value. 4. Inflate using the balloon pump until the reading of sphygmomanometer approximates the preset calibration value. 5. Adjust the preset calibration value until it equals to the reading of the sphygmomanometer. 6. Select the [Calibrate] button next to the desired IBP channel to start calibration. When the calibration is completed, the message [Calibration Completed!] will be displayed. Otherwise, a corresponding message will be displayed. 5-8

45 5.4.7 C.O. Test Tools required: Medsim300B patient simulator, or MPS450, or equivalent equipments C.O. adapter box ( CI-3 module/cable, P/N: for 300B; P/N: for MPS450) C.O. trunk cable (P/N: ) 1. Connect the patient simulator to the C.O. connector on the patient monitor using a C.O. trunk cable and a C.O. adapter box. 2. Set the blood pressure (BT) to 37 C on the patient simulator and check that the temperature value displayed on the monitor is within 37 ± 0.2 C. 3. In the [C.O. Setup] menu on the patient monitor, set [Auto TI] to [Off], [Manual TI ( C)] to 2 C, and [Comp. Const.] to Select [C.O. Measure] to enter the C.O. measurement window. 4. Select [Start] in the C.O. measurement window to start C.O. measurement. 5. On the patient simulator, set C.O. to 5 L/min and wait for 3 to 10 seconds. 6. Verify that the C.O. value displayed on the monitor is 5 ± 0.25 L/min Mainstream CO 2 Tests NOTE Before performing mainstream CO2 tests, select [Main Menu] [Maintenance >>] [User Maintenance >>] enter therequired password [Maintain CO2], and make sure that the setting of [Barometric Pressure] is correct. Tools required: A steel gas cylinder with 6 ± 0.05% CO2 and balance gas N2 A steel gas cylinder with 100% N2 T-shape connector Appropriate tubing Flowmeter 1. Connect the sensor. 2. Wait for 10 minutes until the CO2 warmup is finished and then select [Start Zero Cal.] from [CO2 Setup] menu to start a zero calibration. If the calibration fails, the prompt message [CO2 Zero Failed!] is displayed. Otherwise, the baseline of waveform recovers to zero. 3. In the [CO2 Setup] menu, set [Apnea Delay] to 10 s. 4. Blow to the CO2 sensor to generate a CO2 waveform and then place the sensor in the air. Check if the alarm message [CO2 Apnea] is displayed on the screen. 5-9

46 5. Connect the test system as follows: Gas valve Flowmeter N2 cylinder T-shape connector Mainstream sensor Relief valve T-shape connector Monitor CO2 cylinder 6. Adjust the power supply and turn on/off 3-way valves to ensure that only one cylinder is connected to the Mainstream CO2 sensor via the 3-way valves at one time. 7. Adjust the relief valve and make sure the flowmeter reading is stable and within 2 and 5 L/min. 8. Switch between the two cylinders to connect Mainstream CO2 sensor at an intervals of 6 to 10s and check if the displayed CO2 value is within 45 ± 2 mmhg Sidestream and Microstream CO 2 Tests Leakage Test 1. Connect the CO2 module with the patient module. 2. Wait for 10 seconds until CO2 warmup is finished, and then use your hand or other objects to completely block the gas inlet of the module or watertrap. The sidestream and microstream CO2 modules will behave as follows: Sidestream: The alarm message [CO2 Filter Line Err] is displayed on the screen after 3 seconds. Block the gas inlet for another 60 seconds, and select [User Maintenance >> ] enter the required password [Maintain CO2 >> ] [Calibrate CO2 >>] and check that the current CO2 flow is less than 10 ml/min. If the alarm message does not disappear, it indicates that the module does not leak. Microstream: The alarm message [CO2 Purging] is displayed on the screen after 3 seconds. Block the gas inlet for another 40. If alarm message [CO2 Filter Line Err] is displayed, it indicates that the module does not leak. 5-10

47 Accuracy Test Tools required: A steel gas cylinder with 6 ± 0.05% CO2 and balance gas N2 T-shape connector Appropriate tubing Flowmeter 1. Connect the CO2 module with the patient module. 2. Wait for 10 minutes until the CO2 warmup is finished, and check the airway for leakage and perform a leakage test as well to make sure the airway has no leakage. 3. Select [User Maintenance >> ] enter the required password [Maintain CO2 >> ] [Calibrate CO2 >>]. 4. Connect the test system as follows: Flowmeter Relief valve T-shape connector Sampling line Monitor Cylinder 5. Adjust the relief valve and make sure the flowmeter reading is stable and within 10 and 50 L/min. 6. Check the realtime CO2 value is within 6.0 ± 0.3% in the [Calibrate CO2] menu. Calibration Tools required: A steel gas cylinder with 6 ± 0.05% CO2 and balance gas N2 T-shape connector Appropriate tubing 1. Make sure that the sidestream CO2 module or microstream CO2 module has been warmed up or started up. 2. Check the airway for leakage and perform a leakage test as well to make sure the airway has no leakage. 3. Select [Main Menu] [Maintenance >> ] [User Maintenance >> ] enter the required password [Maintain CO2 >> ] [Calibrate CO2 >>] to enter the [Calibrate CO2] menu. 5-11

48 4. Then select [Zero]. 5. After the zero calibration is finished successfully, connect the equipment as follows: Flowmeter Relief valve Sampling line T-shape connector Monitor Cylinder 6. Adjust the relief valve and make sure the flowmeter reading is stable and within 10 and 50 L/min. 7. In the [Calibrate CO2] menu, enter the vented CO2 concentration in the [CO2] field. 8. In the [Calibrate CO2], the measured CO2 concentration is displayed. After the measured CO2 concentration becomes stable, select [Calibrate CO2] to calibrate the CO2 module. 9. If the calibration is finished successfully, the message [Calibration Completed!] is displayed in the [Calibrate CO2] menu. If the calibration failed, the message [Calibration Failed] is displayed. In this case, perform another calibration AG Tests and Calibration Leakage Test 1. Plug the AG module into the module rack. 2. Wait for a minute until the AG module warmup is finished and then use your hand or other objects to completely block the gas inlet of the AG module. An alarm message [AG Airway Occluded] will be displayed. 3. Block the gas inlet for another 60 seconds, Then select [User Maintenance >> ] [Maintain AG >> ] [Calibrate AG >>] and check that the current flow rate is less than 10 ml/min. If the alarm message does not disappear, it indicates that the module does not leak. Accuracy Test Tools required: Gas cylinder with a certain standard gas (such as 6 ± 0.05% CO2, Bal N2), or standard gas mixture. Gas concentration should meet the following requirements : AA 1.5%, CO2 1.5%, N2O 40%, O2 40%, of which AA represents an anesthetic agent (Des, Sev, Enf, Iso, or Hal). a/c 0.01 (a is the gas absolute concentration accuracy; c is the gas concentration) T-shape connector Appropriate tubing 5-12

49 1. Plug the AG module into the module rack. 2. Wait for at least 10 min and then perform a leakage test to make sure the airway has no leakage. 3. Check if the fan inside the AG module works correctly. 4. Connect the test system as follows: Flowmeter Sampling line Relief valve T-shape connector Monitor Cylinder 5. Adjust the relief valve and make sure the flowmeter reading is stable and within 10 and 50 L/min. 6. Check that the concentration of each composition meets the specification stated in the Operator's Manual. Calibration Tools required: Gas cylinder with a certain standard gas (such as 6 ± 0.05% CO2, Bal N2), or standard gas mixture. Gas concentration should meet the following requirements: AA 1.5%, CO2 1.5%, N2O 40%, O2 40%, of which AA represents an anesthetic agent (Des, Sev, Enf, Iso, or Hal). a/c 0.01 (a is the gas absolute concentration accuracy; c is the gas concentration) T-shape connector Appropriate tubing Follow this procedure to perform the pressure calibration: 1. Select [Main Menu] [Maintenance >> ] [User Maintenance >> ] enter the required password [Calibrate AG >>] to access the [Calibrate AG] menu. 2. Check the airway and make sure that there are no occlusions or leaks. Vent the sampling tubing to the air and check if the [Current Flow Rate] and [Set Flow Rate] are approximately the same. If the deviation is great, it indicates that there is an occlusion in the tubing. Check the tubing for an occlusion. Check the airway and make sure that the airway has no leakage. 5-13

50 3. Connect the test system as follows: Flowmeter Relief valve T-shape connector Sampling line Monitor Cylinder 4. Open the relief valve and vent a certain standard gas or gas mixture. Then adjust the relief valve and make sure the flowmeter reading is stable and within 10 and 50 L/min. 5. In the [Calibrate AG] menu, the concentration and flowrate of each measured gas are displayed. If the difference between the measured gas concentration and the actual one is very small, a calibration is not needed. If the difference is great, you should perform a calibration. Select [Calibrate >>] to enter the calibrate menu. 6. Enter the vented gas concentration. If you use only one gas for calibration, set other gases concentration to Select [Start] to start calibration. 8. If the calibration is finished successfully, the message [Calibration Completed!] is displayed. If the calibration failed, the message [Calibration Failed] is displayed. In this case, perform another calibration. CAUTION Calibrate the O2 module, if it has been transported for long distance. 5-14

51 5.5 Nurse Call Reply Performance Test Tool required: Oscilloscope 1. Connect the nurse call cable to the Multifunctional Connector of the patient monitor. 2. Enter [Demo] mode. Then select [Main Menu] [Maintenance >> ] [User Maintenance >> ] enter the required password [Others >>]. 3. In the [Others >>] menu, select [Nurse Call Setup >>] and then in the [Nurse Call Setup] menu, select all optional [Alm Lev] and [Alm Cat.], and set [Contact Type] to [Normally Open]. 4. In [Nurse Call Setup >>] menu, set [Signal Type] to [Pulse]. Make the monitor to generate an alarm and check that the oscillograph displays positive pulses of 1s width when there is an alarm. 5. In [Nurse Call Setup >>] menu, set [Signal Type] to [Continuous]. Make the monitor to generate an alarm and check that the oscillograph outputs continuous high level when there is an alarm. 5.6 Analog Output Performance Test Tools required: Medsim300B patient simulator, or MPS450, or equivalent equipments Oscilloscope Connect the patient simulator to the monitor using an ECG or IBP cable and connect the oscillograph to the Multifunctional Connector of the patient monitor. Verify that the waves displayed on the oscillograph are identical with those displayed on the monitor. 5.7 Electric Safety Tests See A Electrical Safety Inspection for electrical safety tests. 5-15

52 5.8 Touchscreen Calibration Tool required: None 1. Select [Main Menu] [Maintenance >> ] [Cal. Touchscreen]. 2. The symbol will appear at different positions of the screen. 3. Select, in turn, the central point of the symbol. 4. After the calibration is completed, the message [Screen Calibration Completed!] is displayed. Select [Ok] to confirm the completion of the calibration. 5.9 Recorder Check Tool required: None 1. Print ECG waveforms. The recorder should print correctly and the printout should be clear. 2. Set the recorder to some problems such as out of paper, etc. the patient monitor should give corresponding prompt messages. After the problem is removed, the recorder should be able to work correctly. 3. Switch automatic alarm recording for each parameter ON and then set each parameter s limit outside set alarm limits. Corresponding alarm recordings should be triggered when parameter alarms occur Battery Check Tool required: None Functional Test 1. If the patient monitor is installed with a battery, remove the battery first. 2. Verify that the patient monitor works correctly when running powered form an AC source. 3. Insert the battery per the procedures provided in the Operator s Manual. 4. Remove the AC power cord and verify that the patient monitor still works correctly. Performance Test Perform the test by referring to the Battery chapter in the Operator s Manual and verify the operating time of the battery meets the product specification. 5-16

53 5.11 Factory Maintenance Accessing Factory Maintenance Menu Select [Main Menu] [Maintenance >> ] [Factory Maintenance >> ] enter the required password to access the [Factory Maintenance] menu Drawing Waves There are two methods to draw waves: [Color] and [Mono]. Color: selecting Color will have smoother waveforms. Mono: selecting Mono will have a wider viewing angle Recorder To enable/disable the recorder, select [Recorder] and toggle between [On] and [Off]. NOTE The recorder is disabled if [Recorder] is set to [Off] in the [Factory Maintenance] menu. 5-17

54 Software version Selecting the [Software Version >>] will show software version information, as shown below:

55 In the above figure, 1. System software version 2. Power software version 3. SpO2 software version (0.0 indicates that the monitor is equipped with Nellcor or Masimo SpO2 board) 4. MPM software version 5. External module interface board version Monitor information recording Selecting [Monitor Information >>] will show the status of the patient monitor as shown below: NOTE If the main board is replaced, you need to check the label on the main unit and reconfigure the serial number of the patient monitor. 5-19

56 Maintenance and Test Report (See the above sections for detailed test procedures and contents) Customer name Customer address Servicing person Servicing company Equipment under test (EUT) Model of EUT SN of EUT Hardware version Software version Test equipment Model/No. Effective date of calibration Test Content Visual inspection The case, display screen, buttons, knob, power cord, wall mount, and accessories have no obvious signs of damage. The external connecting cables are not frayed and the connector pins are not loose and bent. The external connectors are not loose or their pins are not bent. The safety labels and data plate are clearly legible. Power-on test The power-on test is passed. The power indicator and alarm system work correctly and the monitor start up properly. Performance test ECG performance test and calibration ECG waves are displayed correctly without noise and the HR value is within 80 ± 1 bpm. ECG Lead Off alarm behaves correctly. Paced signals are detected and pace pulse marks are displayed when [Paced] is set to [Yes]. The difference between the amplitude of the ECG calibration square wave and that of the wave scale is not greater than 5%. RESP test The Resp wave is not distorted and the Resp value is within 40 ± 2 rpm. Test Record Test Result (Pass/Fail) 5-20

57 SpO2 test Measure SpO2 on a healthy person s finger and a Pleth wave and PR value are displayed. The displayed SpO2 value is within 95% and 100%. NIBP test The difference is within ±3 mm when 0, 50 or 200 mmhg is set for NIBP accuracy test. There is no leakage with NIBP, or the manual leakage test result does not exceed 6 mmhg/min. Temp test The value displayed for each Temp channel of the monitor is within 37 ± 0.1 ºC. IBP test and calibration The static pressure value displayed for each IBP channel is within 200 ± 4 mmhg. The ART and LV waves for each IBP channel are displayed correctly. C.O. test The TB value displayed on the monitor is within 37 ± 0.2 ºC. The displayed C.O. value is within 5 ± 0.25 L/min. Mainstream CO2 tests The mainstream CO2 is zeroed successfully and the waveform baseline recovers to zero. CO2 Apnea alarm behaves correctly. The displayed CO2 value is within 6.0 ± 0.3%. Mainstream CO2 tests Block the gas inlet of the module or watertrap. The sidestreamco2 flowrate is slower than 10ml/min and an alarm of CO2 Filterline Err is given. It indicates that there is no leakage. The displayed CO2 value is within 6.0 ± 0.3%. Mainstream CO2 tests Block the gas inlet of the module or watertrap for 40s. An alarm of CO2 Filterline Err is given. It indicates that there is no leakage. The displayed CO2 value is within 6.0 ± 0.3%. AG tests and calibration When AG flowrate is slower than 10ml/min, an alarm of AG Airway Occluded is given. It indicates that there is no leakage. The fan inside the AG module works properly. The measurement accuracy of CO2, N2O, O2 and AA (AA represents an anaesthetic agent) meets the product specifications in the Operator s Manual. Nurse call reply performance test When an alarm is reported on the patient monitor, a nurse call is send out through the cable. Analog output performance test The waves displayed on the oscillograph are identical with those displayed on the monitor. Electric safety tests Refer to A Electrical Safety Inspection. All the electrical safety tests should be passed 5-21

58 Touchscreen calibration The touchscreen is calibrated successfully. Recorder check The recorder can print ECG waves correctly and the printout is clear. Set the recorder to some problems such as out of paper, etc. the patient monitor gives corresponding prompt messages. After the problem is removed, the recorder is able to work correctly. Automatic alarm recording for each parameter functions correctly when parameter alarms occur. Battery check The monitor can operates correctly from battery power when an AC power failure accidentally occurs. The patient monitor can operate independently on a single battery. Test conclusion Tested by: Test date: 5-22

59 6 Troubleshooting 6.1 Introduction In this chapter, patient monitor problems are listed along with possible causes and recommended corrective actions. Refer to the tables to check the patient monitor, identify and eliminate the troubles. The troubles we list here are frequently arisen difficulties and the actions we recommend can correct most problems, but not all of them. For more information on troubleshooting, contact our Customer Service Department. 6.2 Part Replacement Printed circuit boards (PCBs), major parts and components in the patient monitor are replaceable. Once you isolate a PCB you suspect defective, follow the instructions in 7 Disassembly and Repairto replace the PCB with a known good one and check that the trouble disappears or the patient monitor passes all performance tests. Defective PCB can be sent to us for repair. If the trouble remains, exchange the replacement PCB with the original suspicious PCB and continue troubleshooting as directed in this chapter. To obtain information on replacement parts or order them, refer to 8 Parts. 6.3 Checking Patient Monitor Status Some troubleshooting tasks may require you to identify the hardware version and status of your monitor. To check equipment status, 1. Select [Main Menu] [Maintenance >>] [Monitor Information >>]. Then you can view the information on system start time, self check, etc. 2. Select [Main Menu] [Maintenance >>] [Factory Maintenance >>] enter the required password [Monitor Information >>]. You can also view the information on the monitor s current status. 6.4 Checking Software Version Some troubleshooting may involve software compatibility. Thus it requires you to know your monitor configuration and software version. For detailed information on version compatibility, please contact our Customer Service Department. To view information on the system configuration and system software version, 1. Select [Main Menu] [Maintenance >> ] [Software Version >>]. You can also view the information on system software version and module software version. 2. Select [Main Menu] [Maintenance >> ] [Factory Maintenance >> ] enter the required password [Software Version>>]. You can also view the information on system software version and module software version. 6-1

60 6.5 Checking Technical Alarms Before troubleshooting the patient monitor, check for technical alarm messages. If an alarm message is presented, eliminate the technical alarm first. For detailed information on technical alarm message, possible cause and corrective action, refer to the patient monitor s Operation Manual. 6.6 Troubleshooting Guide Power On/Off Failure Symptoms Possible Cause Corrective Action The patient monitor fails to start. AC mains not connected or battery too low Check that AC mains is properly connected or battery capacity is sufficient. Cable defective 1. Check that the cable between the keypad board and main board is correctly connected. 2. Check that the cable between the power board and power management board is correctly connected. 3. Check that the cable between the main board and power management board is correctly connected. Power board defective Replace the power board. Power management board Replace the power management board. defective The main board failed. Replace the main board Display Failures Symptoms Possible Cause Corrective Action The display is blank or black. Cable defective 1. Check if the cable between the display and main board and the backlight cable are correctly connected. 2. Check that the cables and connectors are not damaged. Main board defective Replace the main board. Display defective Replace the display. Images overlapped or distorted Main board error Replace the main board, or upgrade the main board with the upgrade software. Cable defective 1. Check if the cable between the display and main board and the backlight cable are correctly connected. Secondary display does not function or displays snows or flashing specks Cable defective 1. Check that the cable between the secondary display and the monitor is correctly connected. 2. Check that the cable between the main board and power management board is correctly connected. 3. Check that the cable between power management board and interface board is correctly connected. 6-2

61 Symptoms Possible Cause Corrective Action The connector board failed. Replace the connector board. Power management board defective Replace the power management board. The main board failed. Replace the main board. Touchscreen does not Touchscreen disabled respond. Check if there is a symbol displayed above the [Main Menu] quickkey. If yes, press and hold the [Main Menu] quickkey for more than 3 seconds to enable the touchscreen. Cable defective 1. Check that the cable between the touchscreen and touchscreen control board is correctly connected. 2. Check that the cable between the touchscreen control board and main board is correctly connected. Touchscreen control board defective Replace the touchscreen control board Touchscreen defective Replace the touchscreen. The main board failed. Replace the main board. Touch position invalid Touchscreen not calibrated Calibrate the touchscreen Alarm Lamp Failures Symptoms Possible Cause Corrective Action The alarm lamp is not light or extinguished, or the alarm lamp Cable defective 1. Check that the cable between the alarm lamp board and main board is correctly connected. 2. Check that the cables and connectors are not damaged. illuminates Alarm lamp board defective Replace the alarm lamp board abnormally. The main board failed. Replace the main board Button and Knob Failures Symptoms Possible Cause Corrective Action Buttons do not work Cable defective 1. Check that the cable between the keypad board and main board is correctly connected. Keypad board failure Replace the keypad board. Knob does not work Cable defective 1. Check that the cable between the knob and keypad board is correctly connected. 2. Check that the cable between the keypad board and main board is correctly connected. Knob failure Replace the knob encoder. Keypad board failure Replace the keypad board. 6-3

62 6.6.5 Sound Failures Symptoms Possible Cause Corrective Action No hardkey or knob sound, or hardkey or The key volume is set to zero. 1. Select [Main Menu] [Screen Setup >> ] [Key Volume >>] and adjust the key volume to appropriate level. knob sound abnormal Cable defective 1. Check that the cable between the speaker and interface board is properly connected. Speaker defective Replace the speaker. The main board failed. Replace the main board. Power management board defective Replace the power management board. No alarm sound or alarm sound abnormal The alarm sound is set to zero. Select [Main Menu] [Maintenance >>] [User Maintenance >>] enter the required password [Alarm Setup >>] and set the [Minimum Alarm Volume] to appropriate level. Select [Alarm Setup] on the main menu to adjust the alarm volume. Cable defective 1. Check that the cable between the speaker and interface board is properly connected. Speaker defective Replace the speaker. The main board failed. Replace the main board. Power management board defective Replace the power management board Battery Failures Symptoms Possible Cause Corrective Action Battery cannot be Battery defective Replace the battery. charged Cable defective 1. Check that the cable between the battery interface board and power management board is correctly connected. Power management board defective Replace the power management board. Battery interface board defective Replace the battery interface board. NOTE When the battery module has a failure, it may cause problems to other components, In this case, troubleshoot the battery module per the procedure described in the table above. Components of the main unit are powered by the power module. In the event that a component malfunctions, check if the operating voltage is correct. 6-4

63 6.6.7 Recorder Failures Symptoms Possible Cause Corrective Action No printout Recorder module disabled 1. Check if the recorder status indicator lights. 2. If yes, enable the module in the [Factory Maintenance] menu. Otherwise, check for other possible causes. Paper reversed Re-install the paper roll. Cable defective 1. Check that the cable between the recorder and main board is correctly connected. Recorder defective Replace the recorder. Poor print quality or Paper roll not properly Stop the recorder and re-install the paper roll. paper not feeding properly installed Print head dirty 1. Check the thermal print head and the paper roller for foreign matter. 2. Clean the thermal print head with an appropriate clean solution. Recorder defective Replace the recorder Output Interface Failure Symptoms Possible Cause Corrective Action Cable defective 1. Check that the cable between the multi-parameter board and power management board is correctly connected. 2. Check that the cable between power management board and interface board is correctly connected. No analog out signal Multi-parameter board failure Replace the multi-parameter board Power management board defective Replace the power management board. The connector board failed. Replace the connector board. Cable defective 1. Check that the cable between the power management board and main board is correctly connected. 2. Check that the cable between power management board and interface board is correctly connected. Unable to use the The connector board failed. Replace the connector board. USB devices Power management board USB drive data Replace the power management board. defective transfer failure The main board failed. Replace the main board. Select [Main Menu] [Maintenance >> ] [User Improper setup Maintenance >> ] enter the required password [Others >>] and set [Data Transfer Method] to [USB Device]. 6-5

64 6.6.9 Data Storage Failure Symptoms Possible Cause Corrective Action Abnormal patient admitting Admit the patient properly. Fails to review archived patient data SD card full; unavailable for more patient data Delete garbage patient data, remove the related alarm, and readmit the patient. The main board failed. Replace the main board. SD card not formatted Format the SD card. SD card failure SD card failure Replace the SD card. SD card is locked Unlock the SD card. Main board defective Replace the main board Wired Network Related Problems Symptoms Possible Cause Corrective Action Unable to connect the wired network Incorrect LAN cable connection Check LAN cable connection. LAN cable shall not be longer than 50 m. Incorrect IP address configuration Check for IP address conflict. If yes, reconfigure the IP address. Cable defective 1. Check that the cable between the power management board and main board is correctly connected. 2. Check that the cable between power management board and interface board is correctly connected. The connector board failed. Replace the connector board. Power management board Replace the power management board. defective The main board failed. Replace the main board. The monitor is frequently off line or disconnects from the Incorrect LAN cable connection Check LAN cable connection. LAN cable shall not be longer than 50 m. network. The patient monitor is connected to a LAN but Incorrect LAN cable connection Check LAN cable connection. LAN cable shall not be longer than 50 m. cannot view other patients under the View Others mode Excessive requests for viewing the patient monitor at the same time A patient monitor can only be viewed by 4 other patient monitors at the same time under the View Others mode. The excessive view requests system will be ignored. Incorrect IP address configuration Check for IP address conflict. If yes, reconfigure the IP address. 6-6

65 Wi-Fi Related Problems Symptoms Possible Cause Corrective Action The monitor is frequently off line or disconnects from the Wi-Fi network. Unable to connect the Wi-Fi network. The Wi-Fi signal is unstable in Check the signal quality of the hospital Wi-Fi network. the operating area. The monitor's Wi-Fi antenna is Disassemble the monitor and fix the Wi-Fi antenna. detached from or not properly connected with the Wi-Fi module. Wi-Fi antenna defective Replace the Wi-Fi antenna. Wi-Fi module defective Replace the Wi-Fi module. Incorrect IP address Check for IP address conflict. If yes, reconfigure the IP configuration address. The Wi-Fi signal is unstable in Check the signal quality of the hospital Wi-Fi network. the operating area. The monitor's Wi-Fi antenna is Fix the Wi-Fi antenna. detached from or not connected with the Wi-Fi module. Wi-Fi antenna defective Replace the Wi-Fi antenna. Wi-Fi module defective Replace the Wi-Fi module. Main board defective Replace the main board Module Failures Symptoms Possible Cause Corrective Action Failed to connect the external parameter modules Module defective 1. Check that the cable between the external converter board inside the module and the converter board is correctly connected, 2. Replace the converter board. Main unit defective 1. Check that the cable between the main board and power management board is correctly connected. 2. Replace the power management board. 3. Replace the main board. Module can be loaded, but "XX communication Cable defective inside the module Check the cables connecting the converter board and corresponding parameter module. stopped" is reported or some Parameter module defective Replace the corresponding module. parameters cannot be used Converter board defective inside the module Replace corresponding converter board. 6-7

66 Software Upgrade Problems Symptoms Possible Cause Corrective Action Power failure or unintended Boot file upgrade power off during boot file fails upgrade Replace the main board. 1. Check the network connector on the patient monitor. Incorrect network connection 2. Make sure that the hub or switch runs normally. Check that net twines are of the right type and have been connected correctly. Program upgrade Wrong upgrade package has Select package according to system requirement. fails been downloaded Upgrade package shall be.pkg files. Configure a fixed IP address for the patient monitor. Incorrect IP address configuration We recommend not to upgrade a program when the patient monitor is connected to a network with multiple PCs. Battery abnormal Fails to power cycle the patient after upgrading the Upgrade the power management software again monitor after upgrading the power management and then power cycle the patient monitor. power management program program Technical Alarm Messages Refer to the Operator's Manual. 6-8

67 7 Disassembly and Repair 7.1 Tools Required To disassemble and replace the parts and components, the following tools may be required: Philips screwdrivers Tweezers Sharp nose pliers Clamp 7.2 Preparations for Disassembly Before disassembling the equipment, finish the following preparations: Stop patient monitoring, turn off the equipment, and disconnect all the accessories and peripheral devices. Disconnect the AC power source and remove the battery. WARNING Before disassembling the equipment, be sure to eliminate the static charges first. When disassembling the parts labeled with static-sensitive symbols, make sure you are wearing electrostatic discharge protection such as antistatic wristband or gloves to avoid damaging the equipment. Properly connect and route the cables and wires when reassembling the equipment to avoid short circuit. Select appropriate screws to assemble the equipment. If unfit screws are tightened by force, the equipment may be damaged and the screws or part may fall off during use, causing unpredictable equipment damage or human injury. Follow correct sequence to disassembly the equipment. Otherwise, the equipment may be damaged permanently. Be sure to disconnect all the cables before disassembling any parts. Be sure not to damage any cables or connectors. Be sure to place removed screws and disassembled parts properly, preventing them from being lost or contaminated. Place the screws and parts from the same module together to facilitate reassembling. To reassemble the equipment, first assemble the assemblies, and then the main unit. Carefully route the cables. Make sure that the waterproof material is properly applied during reassembling. 7-1

68 7.3 Disassembling the Main Unit NOTE The recorder can be disassembled separately. To disassemble the equipment, place the equipment on a work surface free from foreign material, avoiding damaging the antiglare screen, touchscreen and the knob. Be careful not to break the two cotters on the front ends of rear housing. All the operations should be performed by qualified service personnel only. Make sure to put on the insulating gloves during service operations. Operations relating to optional parts may not apply to your equipment Separating the Front and Rear Half of the Monitor 1. Lay the monitor on a flat platform with the knob overhanging as shown below. Then unscrew the two M3 10 screws on the rear panel and the two M3 6 screws on the bottom of the patient monitor. 2. Stand the patient monitor and separate the front housing assembly and rear housing assembly with caution. Disconnect the cable between the main board and keypad board and then take off the front panel. Cable between the main board and keypad board NOTE When reassembling the equipment, be sure to check if the front housing waterproof strip is correctly placed. 7-2

69 7.3.2 Disassembling Parameter Modules Lay the patient monitor on a flat platform and unscrew the five M3 5 screws as shown below. Disconnect the cable between the power management board and multi-parameter board, and then take out the parameter module. Cable between the power management board and multi-parameter board Removing the Parameter Connector Panel Assembly Unscrew the three M3 6 screws as shown below and separate the parameter connector panel assembly and parameter board assembly Removing the SpO 2 Board and Parameter Board 1. Unscrew the two M3 4 screws and take out the SpO2 board and insulation plate. 7-3

70 2. Unscrew the four M3 6 screws, disconnect the pump cable and valve cable, and then take out the SpO2 board. Pump cable Valve cable Removing Pump and Valve Unscrew the two M3 6 screws and take out the valve. Then cut the two fixing strips to take out the pump Removing the Recorder (Optional) Unscrew the four M3 6 screws and disconnect the recorder cable to remove the recorder. NOTE The recorder can be disassembled separately. 7-4

71 7.3.7 Removing Battery Interface Board and Power Board (ipm 5/iPM 6/iPM 8/iPM 10) 1. Unscrew the three M3 6 screws inside the patient monitor and the four M3 6 screws on the bottom as shown below: 2. Disconnect the cable between battery interface board and power management board, and the cable between the power management board and AC/DC power board. Then take out the battery compartment assembly. Cable between the power management board and AC/DC power board Cable between the battery in terface board and power ma nagement board 3. Unscrew the two M3 nuts to take out the battery interface board. 4. Unscrew the three M3 6 screws to remove the AC/DC power board. 7-5

72 5. Unscrew the M3 6 screw and the flat head screw fixing the AC input receptacle assembly, then loose the screw that fixes the grounding cable to take out the AC input receptacle assembly Removing the Battery Interface Board and Power Board (ipm 7/iPM 12) 1. Unscrew the two M3 6 screw inside the patient monitor and then the two M3 6 screws on the bottom. Then disconnect the cable between the battery interface board and power management board to remove the battery compartment assembly. 2. Unscrew the four M3 6 screws to take out the battery interface board assembly. 3. Unscrew the two M3 6 screws inside the patient monitor and then the two M3 6 screws on the bottom. Then disconnect the cable between the battery interface board and the power management board to remove the power board assembly. 7-6

73 4. Unscrew the five M3 6 screws that fix the AC input receptacle assembly and then the screw that fixes the grounding cable. Unplug the AC input receptacle and cable from the board to remove the AC input receptacle assembly. AC input receptacle and cable 5. Unscrew the three M3 6 screws to remove the AC/DC power board Removing the Power Management Board Unscrew the seven M3 6 screws inside the patient monitor, disconnect all the cables, and then take out the power management board. 7-7

74 Removing the Interface Board (ipm 5/iPM 8) Unscrew the three M3 6 screws inside the patient monitor and take out the interface board Removing the Interface Board (ipm 6/iPM 7/iPM 10/iPM 12) Unscrew the three M3 6 screws inside the patient monitor and take out the interface board. 7.4 Disassembling the Front Housing Assembly NOTE To disassemble the equipment, place the equipment on a work surface free from foreign material, avoiding damaging the antiglare screen, touchscreen and the knob. Remember to install the screen support pad properly during reassembly. Operations relating to optional parts may not apply to your equipment. Position the touchscreen properly with the flexible cable facing down. 7-8

75 7.4.1 Removing Touchscreen Control Board (Optional) Loose and unscrew the two M3 6 screws as shown below. Disconnect the touchscreen cable and cable for touchscreen control board, and then remove the touchscreen control board. Touchscreen cable Removing the Wi-Fi Module (Optional) 1. Take out the two antennas on the front panel from the slots as shown below: Antenna Antenna 2. Remove the antennas from the Wi-Fi module PCBA. Antenna Antenna 7-9

76 3. Push the clamps aside to remove the Wi-Fi module. Clamps Clamps Removing SD Card (Optional) Unscrew the M3 6 screw, and push the SD card as indicated below to take out the SD card Removing the Main Control Board Disconnect the alarm lamp cable, cable for display backlight, display cable, and the cable between the main board and keypad board respectively. Unscrew the four M3 8 screws and take out the main board, as shown below: 7-10

77 7.4.5 Removing the Touchscreen (Optional) Unscrew the nine M3 6 screws as indicated below. Take out the touchscreen assembly and then the touchscreen Disassembling the Screen Unscrew the four M3 6 screws indicated below to remove the screen Removing the Keypad Unplug the encoder cable and unscrew the five PT3 8 screws indicated below. Take out the keypad Removing the Encoder Poke the encoder knob out from the slot and loose the nut with a sharp nose plier. Take out the encoder. Knob 7-11

78 7.4.9 Removing the Alarm Lamp Board Unscrew the two M3 6 screws indicated below and take out the alarm lamp board. 7.5 Disassembling Modules Removing the External Converter Board Unscrew the four M3 8 screws and disconnect the cable between the converter board and copper board to remove the converter board. Cable between the converter board and copper board Separating the Front and Rear Housing of Modules 1. For AG modules, unscrew the four M3 8 screws on the bottom before separating the front and rear housing. 7-12

79 2. For other modules, unscrew the two M3 6 screws on the back to separate the front and rear housing Removing the External Module Interface Board Unscrew the two M3 6 screws, disconnect all the cables from the board, and then remove the module interface board Removing M03B Module Disconnect all the cables from the M03B module and push the clamp on the bracket to remove the M03B module. Clamp 7-13

80 7.5.5 Removing Sidestream CO 2 Module 1. Unscrew the 3 screws that fix the bracket and connector panel. Disconnect all the cables and tubes that connect the bracket and connector panel. Then separate the connector panel and bracket. NOTE Manage the tubes properly during reassembly and make sure the tubes shaping smooth. 2. Unscrew the four screws that fix the M02C module, and then take out the M02C module Removing Microstream CO 2 Module 1. Unscrew the 3 screws that fix the bracket and connector panel. Disconnect all the cables and tubes that connect the bracket and connector panel. Then separate the connector panel and bracket. 7-14

81 2. Unscrew the three M3 8 screws that fix the microstream CO2 module, and then remove the microstream CO2 module Removing AG Module 1. Unscrew the three M3 6 screws and the captive screw that fix the AG module bracket and connector panel. Then disconnect all the cables and tubes connecting the connector panel and the AG module to separate the connector panel and bracket. 2. Unscrew the six M3 6 screws that fix the AG module and remove AG module. NOTE Manage the tubes properly during reassembly and make sure the tubes shaping smooth. 7-15

82 FOR YOUR NOTES 7-16

83 8 Parts 8.1 Introduction This section contains the exploded views and parts lists of the main unit. It helps the engineer to identify the parts during disassembling the patient monitor and replacing the parts. This manual is based on the maximum configuration. Your equipment may not have same parts and the quantity of the screws or stacking sleeves etc. may be different with those included in the parts lists. Hardware architecture of the main unit is shown below: NOTE The part number listed in the Parts List is only for checking the FRU part number which is also included in the Parts List. Please provide the FRU parts number if you want to purchase the spare parts. 8-1

84 8.2 ipm 8/iPM Main Unit Exploded View Parts List SN PN Description FRU part number Remarks 1 / Rear housing assembly (ipm 8) Only for ipm 8 / / Rear housing assembly (ipm5) Only for ipm TR6F recorder (Datascope) / Recorder door (MR-DS193) For monitors without recorder 3 Multi-parameter assembly (3-/5-lead, Nellcor / SpO2) / / 4 / Screw, Pan head with washer, Phillips M3 6 / / 5 / Front housing assembly (ipm 8, touchscreen) / Only for ipm 8 / Front housing assembly (ipm 5, touchscreen) / Only for ipm 5 6 / Screw, pan head, Phillips, M3 6 / / 7 / Screw, pan head Phillips, M3 8 / / Hook assembly (ipm 8, right) / Hook assembly (ipm 8, left) / 10 / Main unit label / / 8-2

85 8.2.2 Front Housing Subassembly (Touchscreen) Exploded View Parts List SN PN Description FRU part number Remarks " front panel (ipm 8) 3 / Alarm lamp gasket 4 / Alarm lamp shade 5 / Touchscreen position pad (8") 6 / Long gasket, ipm 8, touchscreen 7 / Short gasket, ipm 8, touchscreen 12 / Locking plate 14 / Semicircle foot pad 15 / Square foot pad 27 / Tube, white, 1.6 mm OD 0.8 mm Only for ipm 8; The color of both the front panel and rear panel has been changed. Color difference may result if either is replaced separately " front panel (ipm 5) 3 / Alarm lamp gasket Only for ipm 5 8-3

86 SN PN Description FRU part number Remarks 4 / Alarm lamp shade 5 / Touchscreen position pad (8") 6 / Long gasket, ipm 8, touchscreen 7 / Short gasket, ipm 8, touchscreen 12 / Locking plate 14 / Semicircle foot pad 15 / Square foot pad 27 / Tube, white, 1.6 mm OD 0.8 mm Alarm lamp board PCBA / Knob for ipm Only for ipm Knob for ipm Only for ipm 8 / ipm Wi-Fi module kit Cyberlink module PCBA The two parts below are included in this kit Antenna cable Encoder board / Encoder cable / 13 / Screw, self-tapping, PT3 8 / / 16 Cable between the touchscreen control board and the main board / Signal cable for 8" screen / 18 Cable between the main board and backlight board (8") / 19 / Bracket for 8" screen / / Touchscreen control board PCBA / Screw, Pan head with washer, Phillips 21 / M3 6 / / Cable between main board and keypad board / Main board PCBA / 24 / Inner hexagon screw, M3 6 / / Cable between mother board and alarm lamp / AU LCD (ipm 8) / Touchscreen, resitive-type, 8.4" 4-line / Keypad board PCBA, 8.4 inch / Power button / " button (English) / " button (Chinese) / Industrial SD card (SLC), 1G / 8-4

87 8.2.3 Front Housing Assembly (Nakescreen) Exploded View Parts List SN PN Description FRU part number Remarks " front panel (ipm 8) 3 / Alarm lamp gasket 4 / Alarm lamp shade 5 / Long gasket, ipm 8, nakescreen 6 / Short gasket, ipm 8, nakescreen 10 / Locking plate 12 / Semicircle foot pad 13 / Square foot pad 23 / Tube, white, 1.6 mm OD 0.8 mm " front panel (ipm 5) Only for ipm 8; The color of both the front panel and rear panel has been changed. Color difference may result if either is replaced separately. 3 / Alarm lamp gasket Only for ipm 5 4 / Alarm lamp shade 8-5

88 SN PN Description FRU part number Remarks 5 / Long gasket, ipm 8, nakescreen 6 / Short gasket, ipm 8, nakescreen 10 / Locking plate 12 / Semicircle foot pad 13 / Square foot pad 23 / Tube, white, 1.6 mm OD 0.8 mm Alarm lamp board PCBA / Knob for ipm Only for ipm Knob for ipm Only for ipm Encoder board / Encoder cable / 11 / Screw, self-tapping, PT3 8 / / " AU LCD / 15 Cable between the main board and backlight board (8") / Signal cable for 8" screen / 17 / Bracket for 8" screen / / 18 Cable between main board and alarm lamp / Screw, Pan head with washer, Phillips 19 / M3 6 / / Cable between main board and keypad board / Main board PCBA / 22 / Inner hexagon screw, M3 6 / / 24 / Plate / / Keypad board PCBA, 8.4 inch / / ipm 8/10 Wi-Fi module kit Cyberlink module PCBA The two parts below are included in this kit Antenna cable Power button / " button (English) / " button (Chinese) / Industrial SD card (SLC), 1G / 8-6

89 8.2.4 Rear Housing Assembly Exploded View Parts List SN PN Description FRU part number Remarks Only for ipm 8; The color of both the front panel and rear panel has been changed. Color difference may result if either is / Rear housing assembly (ipm 8) replaced separately. / Rear housing assembly (ipm 5) Only for ipm 5 2 / Speaker pad / / Speaker, 2W, 4ohm, 500 Hz / 4 / Speaker bracket (ipm 8) / / Interface converter kit (ipm 8, full config) Interface converter kit (ipm 8, USB, no DC_IN) different configuration Interface converter kit (ipm 8, no USB, no DC_IN) Power management and interface board (full config, USB) Power management and interface board (full 3 different configuration config, USB, DC_IN) Power management and interface board / Thermal gel / / 9 / Main bracket assembly (ipm 8) / / 8-7

90 SN PN Description FRU part number Remarks 10 / Screw, Pan head with washer, Phillips M3 6 / / 11 / Door spindle (ipm 8) / / 12 / Battery door assembly (ipm 8/iPM 10) / AC Inlet Hook / 14 / Screw, pan head, Phillips, M3 6 / / 15 Cable between the interface board and main board / 16 Cable between power management board and I/O interface board / 17 Cable between the power management board and parameter board / Recorder cables / 19 / Fixing strip / / USB plug / DC plug / Multi-parameter Assembly Exploded View 8-8

91 Parts List SN PN Description FRU part number Remarks / Parameter connector assembly (Mindray SpO2) ipm 5/6/8/ 10 / Parameter connector assembly (Nellcor SpO2) different / Parameter connector assembly (Masimo SpO2) configuration / Parameter connector assembly (ipm 12, Mindray SpO2) / Parameter connector assembly (ipm 12, Nellcor SpO2) ipm 7/12 / Parameter connector assembly (ipm 12, Masimo SpO2) different / Parameter connector assembly (ipm 12, Mindray SpO2, IBP) configuration / Parameter connector assembly (ipm 12, Nellcor SpO2, IBP) / Parameter connector assembly (ipm 12, Masimo SpO2, IBP) / NIBP pump and valve kit / / 3 / 3-way silicone tube / / 4 / Plastic connector / / 5 / Hexagon plastic nut, M3 0.5P, PC / / ipm multi-parameter board PCBA (full config) kinds of ipm multi-parameter board PCBA (5-Lead, complete) ipm multi-parameter board PCBA (complete) parameter board 7 / Plastic hexagon bolt / / 8 / SpO2 board insulator / / 9 / Screw, pan head Phillips, M3 4 / / V2.0 SpO2 board PCBA Nellcor SpO2 board (MDU) Masimo MS-2013 SpO2 board (For Shenzhen Mindray only) kinds of SpO2 board 11 / Connector / / 12 / Silicon tube, 3/32" 7/32" 100 ft / / 13 / Screw, Pan head with washer, Phillips M3 6 / / 8-9

92 8.2.6 Battery Compartment Assembly Exploded View Parts List SN PN Description FRU part number Remarks 1 / Main bracket (ipm 8) / / 2 / Power bracket sheet / / 3 / Battery fastener (ipm 8/iPM 10) / AC/DC power board / 5 / AC input receptacle assembly (ipm 8/iPM 10) / 6 / Power sheet (ipm 8) / / 7 / Screw, Pan head with washer, Phillips M3 6 / / 8 / Recorder adjustment bracket / / 9 / M3 nut with spring washer / / 10 / Battery connector board (ipm 8/iPM 10) / 11 / Spring, EMI / / 12 / Screw, Pan head with washer, Phillips M4 8 / / 13 / Screw, pan head, Phillips, M3 6 / / Cable between the power management board and AC/DC power board / 8-10

93 8.2.7 NIBP Pump and Valve Kit Exploded View Parts List SN PN Description FRU part number Remarks 1 / Multi-parameter board bracket / / 2 / Shock absorption cushion for pump / / 3 / Nylon fixing strip / / 4 / Pump, P54C06R / 6 / Valve cushion / 11 / Cable between the pump and multi-parameter board / Gas valve, CJV13-A12B / 7 / 630F reducer / / 8 / NIBP pipe / / 9 / Screw, Pan head with washer, Phillips M3 6 / / 10 / Valve bracket / / 8-11

94 8.2.8 IBP_C.O. Module Assembly Exploded View Parts List SN PN Description FRU part number Remarks 1 / Front housing of A1 module / Module indicator and cable / 2 / Silicone tube / IBP signal cable (3-way) / 5 / Connecting sheet for A1 module bracket / / 6 / Screw, Pan head with washer, Phillips M3 6 / / Bracket for A module / 8 M03B CO/IBP (M03B) module M03B / Cable between the converter board and M03B module / A module button / 11 / Spring washer / / 12 / Screw, pan head, Phillips, M3 8 / / 13 / Module label (no manufacturer information) / / External converter board (plug-in modules) / Lock for A module / Rear housing of A modules / Cable between the converter board and copper board / External module interface board (IBP_C.O.) / External module interface board (IBP) / 19 / Screw, self-tapping, PT3 8 / / 8-12

95 SN PN Description FRU part number Remarks C.O. signal cable / Decorative IBP socket / 22 / DP 105 epoxy resins / / IBP_C.O._Sidestream CO 2 Module Assembly/ IBP_Sidestream CO 2 Module Assembly Exploded View Parts List SN PN Description FRU part number Remarks AG watertrap receptacle (no pipe, ) / 2 / Gas outlet / / 3 / Front housing of A2 module (2ch-IBP + C.O. + Mindray CO2) / 4 / Double IBP receptacle (9281) / 30 / C.O._IBP interface board (ipm) / 31 / C.O. module, single receptacle / 32 / Silicone tube / Module indicator and cable / 5 / Screw, self-tapping, PT3 8 / / 8-13

96 SN PN Description FRU part number Remarks 6 / Nut, Stainless Steel M5 GB6170 / / IBP/C.O. signal cable (4-way) / 8 / AG airway sampling line (1.4/2.8) / / 9 / AG airway sampling line (2.2/4.4) / / 10 / Moisture exchanger (Nafion Tube for Mindray CO2) / / 11 / Screw, pan head Phillips, M3 8 / / 12 M03B C.O./IBP (M03B) module M03B / 13 / Sampling line insulator for A module / / 14 / CO2 module unit (M02C) / / Cable between converter board and M03B module / A module button / 17 / Spring washer / / External converter board (plug-in modules) / 19 / Module label (no manufacturer information) / / 20 / Screw, pan head, Phillips, M3 8 / / Lock for A module / 22 / Screw, Pan head with washer, Phillips M3 6 / / Rear housing of A modules / Bracket for A module / Cable between the converter board and copper board / External module interface board (IBP_C.O._Sidestream CO2) / External module interface board (Sidestream CO2) / M02C module cable / 29 / Connecting sheet for A1 module bracket / / Decorative IBP socket / 34 / DP 105 epoxy resins / / 35 / Silicone tube / / 36 / Air filter / / 8-14

97 IBP_C.O._Microstream CO 2 Module Assembly/IBP_Microstream CO 2 Module Assembly Exploded View Parts List SN PN Description FRU part number Remarks 1 / Front housing of A3 module (2ch-IBP + C.O. + Microstream CO2) / 2 / Silicone tube / 3 / Double IBP receptacle (9281) / 4 / C.O._IBP interface board (ipm) / Module indicator and cable / 31 / C.O. module, single receptacle / 5 / Screw, self-tapping, PT3 8 / / IBP/C.O. signal cable (4-way) / Cable between the Microstream CO2 module and converter board / Cable between the converter board and M03B module / 10 M03B C.O./IBP (M03B) module M03B / 11 / CO2 bracket for A module / / 12 / Microstream CO2 module; / / 8-15

98 SN PN Description FRU part number Remarks 13 / Screw, pan head Phillips, M3 6 / / 14 / IBP insulator for A module / / A module button / 16 / Spring washer / / 17 / Screw, pan head, Phillips, M3 8 / / 18 / Module label (no manufacturer information) / / External converter board (plug-in modules) / Lock for A module / 21 / Screw, Pan head with washer, Phillips M3 6 / / Rear housing of A modules / Bracket for A module / Cable between the converter board and copper board / External module interface board (IBP_C.O._Microstream CO2) / External module interface board (Microstream CO2) / 26 / Connecting sheet for A1 module bracket / / 27 / Microstream CO2 module connector / / 28 / Spring washer / / 29 / Nut, Stainless Steel M5 GB6170 / / 30 / Microstream CO2 connector fixing spring / / 32 / Microstream CO2 connector baffle / / 33 / Gas outlet / / Decorative IBP socket / 35 / DP 105 epoxy resins / / 8-16

99 IBP_C.O._Mainstream CO 2 Module Assembly/IBP_Mainstream CO 2 Module Assembly Exploded View Parts List SN PN Description FRU part number Remarks 1 / Front housing of A4 module (2ch-IBP + C.O. + Mainstream CO2) / 2 / Silicone tube / 3 / Double IBP receptacle (9281) / 4 / C.O._IBP interface board (ipm) / Module indicator and cable / 23 / C.O. module, single receptacle / 5 / Connecting sheet for A1 module bracket / / 6 / Screw, self-tapping, PT3 8 / / IBP/C.O. signal cable (4-way) / Bracket for A module / Cable between the converter board and M03B module / 11 M03B C.O./IBP (M03B) module M03B / A module button / 13 / Spring washer / / 14 / Screw, pan head, Phillips, M3 8 / / 8-17

100 SN PN Description FRU part number Remarks 15 / Module label (no manufacturer information) / / External converter board (plug-in modules) / Lock for A module / Rear housing of A modules / Cable between the converter board and copper board / / External module interface board (IBP_C.O._Mainstream CO2) / External module interface board (Mainstream CO2) / Mainstream CO2 signal cable / 22 / Screw, Pan head with washer, Phillips M3 6 / / Decorative IBP socket / 25 / DP 105 epoxy resins / / 8.3 ipm 10/iPM Main Unit Exploded View 8-18

101 Parts List SN PN Description FRU part number Remarks 1 / Rear housing assembly (ipm 10) / / TR6F recorder (Datascope) / Recording cover (MR-DS193) For monitors without recorder 3 / Multi-parameter assembly (3-/5-lead, Nellcor SpO2) / / 4 / Screw, Pan head with washer, Phillips M3 6 / / 5 / Front housing assembly (ipm 10, touchscreen) / Only for ipm 10 / Front housing assembly (ipm 6, touchscreen) / Only for ipm 6 6 / Screw, pan head, Phillips, M3 6 / / 7 / imec12 rear label (CN) / / 8 / Hook (ipm 10) / 9 / Screw, Pan head with washer, Phillips M3 10 / / Front Housing Subassembly (Touchscreen) Exploded View 8-19

102 Parts List SN PN Description FRU part number Remarks " front panel (ipm 10) 2 / Alarm lamp shade 3 / Alarm lamp gasket 8 / Gasket 1, ipm 10, touchscreen Only for ipm 10; The color 9 / Gasket 2, ipm 10, touchscreen of both the front panel 10 / Touchscreen position pad (ipm 12) and rear panel has been / Touchscreen position pad (ipm 10/iPM 12) changed. Color difference 22 / Gasket 3, ipm 10, touchscreen may result if either is 23 / Locking plate replaced separately. 24 / Semicircle foot pad 25 / Square foot pad 32 / Tube, white, 1.6 mm OD 0.8 mm " front panel (ipm 6) 2 / Alarm lamp shade 3 / Alarm lamp gasket 8 / Gasket 1, ipm 10, touchscreen 9 / Gasket 2, ipm 10, touchscreen 10 / Touchscreen position pad (ipm 12) 12 / Touchscreen position pad (ipm 10/iPM 12) Only for ipm 6 22 / Gasket 3, ipm 10, touchscreen 23 / Locking plate 24 / Semicircle foot pad 25 / Square foot pad 32 / Tube, white, 1.6 mm OD 0.8 mm Alarm lamp board PCBA / 5 / Screw, Pan head with washer, Phillips M3 6 / / Encoder cable / / ipm Wi-Fi module kit Cyberlink module PCBA The two parts below are included in this kit Antenna cable Touch panel, resitive-type, 10.4" 4-line / 13 Cable between main board and alarm lamp board / Touchscreen control board PCBA / 15 Cable between main board and keypad board / Main board PCBA / 17 / Inner hexagon screw, M3 6 / / Signal cable for 10" screen / 8-20

103 SN PN Description FRU part number Remarks Cable between the touchscreen control board and the main board / 20 / 10" AU LCD service kit / Cable between the main board and backlight board (12") / 26 / Screw, self-tapping, PT3 8 / / Keypad board PCBA, 10.4 inch / Power button / Button (for ipm 8) / Encoder board / Knob For ipm 10/ Knob For ipm 6/ Industrial SD card (SLC), 1G / Front Housing Assembly (Nakescreen) Exploded View 8-21

104 Parts List SN PN Description FRU part number Remarks " front panel 2 / Alarm lamp shade 4 / Tube, white, 1.6 mm OD 0.8 mm 11 / Gasket 3, ipm 10, touchscreen 12 / Gasket 4, ipm 10, touchscreen 20 / Locking plate 21 / Semicircle foot pad 22 / Square foot pad 5 / Alarm lamp gasket " front panel (ipm 6) 2 / Alarm lamp shade 4 / Tube, white, 1.6 mm OD 0.8 mm 11 / Gasket 3, ipm 10, touchscreen Only for ipm 10; The color of both the front panel and rear panel has been changed. Color difference may result if either is replaced separately. 12 / Gasket 4, ipm 10, touchscreen Only for ipm 6 20 / Locking plate 21 / Semicircle foot pad 22 / Square foot pad 5 / Alarm lamp gasket For ipm 10/ Knob For ipm 6/ Alarm lamp board PCBA / 7 / Screw, Pan head with washer, Phillips M3 6 / / Encoder board / Encoder cable / / ipm Wi-Fi module kit Cyberlink module PCBA The two parts below are included in this kit Antenna cable Cable between main board and alarm lamp board / Main board PCBA / Cable between main board and keypad board / 16 / Inner hexagon screw, M3 6 / / Signal cable for 10" screen / 18 / 10" AU LCD service kit / Cable between the main board and backlight board (12") / 23 / Screw, self-tapping, PT3 8 / / Keypad board PCBA, 10.4 inch / 8-22

105 SN PN Description FRU part number Remarks Power button / " button (English) / " button (Chinese) / Industrial SD card (SLC), 1G / Rear Housing Assembly Exploded View Parts List SN PN Description FRU part number Remarks Only for ipm 10; The color of both the front panel and rear panel has been changed. Color difference may result if / Rear housing assembly (ipm 10) either is replaced separately. / Rear housing assembly (ipm 6) Only for ipm 6 2 / Speaker pad / / Speaker, 2W, 4ohm, 500 Hz / 4 / Speaker bracket (ipm 8) / / 5 / I/O interface waterproof pad (ipm 10) / / Interface converter board (ipm 10, full config, USB) 2 different configuration Interface converter board (ipm 10) Power management and interface board (full config, USB) different configuration Power management and interface board

106 SN PN Description FRU part number Remarks 8 / Battery compartment assembly (ipm 10) / / 9 / Screw, Pan head with washer, Phillips M3 6 / / 10 / Door spindle (ipm 8) / / 11 / Battery door assembly (ipm 8/iPM 10) / AC Inlet Hook / 13 / Screw, pan head, Phillips, M3 6 / / 14 Cable between the power management board and recorder / 15 Cable between the interface board and main board / 16 Cable between the interface board and main board / 17 Cable between the power management board and parameter board / 18 / Fixing strip / / USB plug / Battery Compartment Assembly Exploded View Parts List SN PN Description FRU part number Remarks 1 / Main bracket (ipm 10) / / 2 / Power bracket sheet / / 8-24

107 SN PN Description FRU part number Remarks 3 / Battery fastener (ipm 8/iPM 10) / AC/DC power board / 5 / AC input receptacle assembly (ipm 8/iPM 10) / 6 / Power sheet (ipm 10) / / 7 / Screw, Pan head with washer, Phillips M3 6 / / 8 / Recorder adjustment bracket / / 9 / M3 nut with spring washer / / 10 / Battery connector board (ipm 8/iPM 10) / 11 / Spring, EMI / / 12 / Screw, Pan head with washer, Phillips M4 8 / / 13 / Screw, pan head, Phillips, M3 6 / / Cable between the power management board and AC/DC power board / Multi-parameter Assembly For the exploded view and parts list of the multi-parameter assembly, refer to Section Multi-parameter Assembly NIBP Pump and Valve Kit For the exploded view and parts list of the NIBP pump and valve kit, refer to Section NIBP Pump and Valve Kit IBP_C.O. Module Assembly For the exploded view and parts list of the IBP_C.O. module assembly, refer to Section IBP_C.O. Module Assembly IBP_C.O._Sidestream CO 2 Module Assembly/IBP_Sidestream CO 2 Module Assembly For the exploded view and parts list of the IBP_C.O._Siderstream CO2 module assembly and IBP_Sidestream CO2 module assembly, refer to Section IBP_C.O._Sidestream CO2 Module Assembly/ IBP_Sidestream CO2 Module Assembly IBP_C.O._Microstream CO 2 Module Assembly/IBP_Microstream CO 2 Module Assembly For the exploded view and parts list of the IBP_C.O._Microstream CO2 module assembly and IBP_Microstream CO2 module assembly, refer to Section IBP_C.O._Microstream CO2 Module Assembly/IBP_Microstream CO2 Module Assembly IBP_C.O._Mainstream CO 2 Module Assembly/IBP_Mainstream CO 2 Module Assembly For the exploded view and parts list of the IBP_C.O._Mainstream CO2 module assembly and IBP_Mainstream CO2 module assembly, refer to Section IBP_C.O._Mainstream CO2 Module Assembly/IBP_Mainstream CO2 Module AssemblyIBP_C.O._Mainstream CO2 Module Assembly. 8-25

108 IBP_C.O._AG Module Assembly/ IBP_AG Module Assembly Exploded View Parts List SN PN Description FRU part number Remarks AG watertrap receptacle / / 2 / Gas outlet / / 3 / Front housing of B1 module / 5 / Silicone tube / 7 / Module indicator and cable / 4 / Nut, Stainless Steel M5 GB6170 / / IBP signal cable (3-way) / Cable between the AG module and converter board / Cable between the converter board and M03B module / 10 M03B C.O./IBP (M03B) module M03B / 11 / IBP insulator for B module / / External module interface board (RS232) / 13 / Screw, pan head Phillips, M3 6 / / 14 / Screw, pan head, Phillips, M3 8 / / A module button / 16 / Spring washer / / 8-26

109 SN PN Description FRU part number Remarks 17 / Screw, Pan head with washer, Phillips M3 6 / / 18 / Screw, self-tapping, PT3 10 / / 19 / Module label (no manufacturer information) / / External converter board (B modules) / Lock for B module / Rear housing of B modules / / Cable between the converter board and copper board / / 24 / Bracket for B1 module / / 25 / B module pipe shield / / 26 / AION 2.5G AG module (AG + O2 + SPM) / / C.O. signal cable / 28 / AG airway sampling line (1.4/2.8) / / 29 / AG airway sampling line (2.2/4.4) / / 30 / DP 105 epoxy resins / / 8.4 ipm 12/iPM Main Unit Exploded View 8-27

110 Parts List SN PN Description FRU part number Remarks 1 / Rear housing assembly (ipm 12) / Only for ipm 12 / Rear housing assembly (ipm 7) / Only for ipm TR6F recorder (Datascope) / Recording cover (MR-DS193) For monitors without recorder 3 / Multi-parameter assembly (ipm 12, 3-/5-lead, Mindray SpO2) / / 4 / Front housing assembly (ipm 12, touchscreen) / / 5 / Screw, Pan head with washer, Phillips M3 6 / / 6 / Screw, pan head, Phillips, M3 6 / / 7 / imec12 rear label (CN) / / 8 / Screw, Pan head with washer, Phillips M3 10 / / 9 / Hook (ipm 10) / Front Housing Subassembly (Touchscreen) Exploded View 8-28

111 Parts List SN PN Description FRU part number Remarks " front panel Only for ipm 12; 3 / Alarm lamp gasket The color of both 4 / Alarm lamp shade the front panel 5 / Long gasket, ipm 12, touchscreen and rear panel 6 / Short gasket, ipm 12, touchscreen has been / Long gasket, ipm 12, nakescreen changed. Color 11 / Square foot pad difference may 12 / Semicircle foot pad result if either is 13 / Locking plate replaced separately. 28 / Tube, white, 1.6 mm OD 0.8 mmid " front panel (ipm 7) 3 / Alarm lamp gasket 4 / Alarm lamp shade 5 / Long gasket, ipm 12, touchscreen 6 / Short gasket, ipm 12, touchscreen Only for ipm 7 7 / Long gasket, ipm 12, nakescreen 11 / Square foot pad 12 / Semicircle foot pad 13 / Locking plate 28 / Tube, white, 1.6 mm OD 0.8 mmid Alarm lamp board PCBA / For ipm 10/12 Knob For ipm 6/ Encoder board / Encoder cable / / ipm12 Wi-Fi module kit The parts listed Cyberlink module PCBA below is Antenna cable included in the / Antenna service kit (ipm 12) kit Touchscreen control board PCBA / Cable between main board and keypad board / 17 Cable between the touchscreen control board and the main board / 18 / Inner hexagon screw, M3 6 / / Main board PCBA / Cable between the main board and backlight board (12") / Cable between main board and alarm lamp board / Signal cable for 12" screen / 8-29

112 SN PN Description FRU part number Remarks " AU LCD service kit / Touch-panel, resitive-type, 12.1" 4-line / 25 / Screw, self-tapping, PT3 8 / / Keypad board PCBA, 12 inch / Power button / " button (English) / " button (Chinese) / 30 / Screw, Pan head with washer, Phillips M3 6 / / Industrial SD card (SLC), 1G / Front Housing Assembly (Nakescreen) Exploded View Parts List SN PN Description FRU part number Remarks " front panel 14 / Square foot pad 15 / Semicircle foot pad 16 / Locking plate 17 / Short gasket, ipm 12, nakescreen 18 / Long gasket, ipm 12, nakescreen 4 / Alarm lamp gasket Only for ipm 12; The color of both the front panel and rear panel has been changed. Color difference may result if either is

113 SN PN Description FRU part number Remarks 5 / Alarm lamp shade replaced separately. 6 / Tube, white, 1.6 mm OD 0.8 mmid " front panel (ipm 7) 14 / Square foot pad 15 / Semicircle foot pad 16 / Locking plate 17 / Short gasket, ipm 12, nakescreen Only for ipm 7 18 / Long gasket, ipm 12, nakescreen 4 / Alarm lamp gasket 5 / Alarm lamp shade 6 / Tube, white, 1.6 mm OD 0.8 mmid Power button / For ipm 10/12 Knob For ipm 6/ " button (English) / " button (Chinese) / Encoder board / 2 / Screw, Pan head with washer, Phillips M3 6 / / Alarm lamp board PCBA / Keypad board PCBA, 12 inch / 12 / Screw, self-tapping, PT3 8 / / Encoder cable / 19 / 12" AU LCD service kit / / ipm12 Wi-Fi module kit The parts listed Cyberlink module PCBA below is included in Antenna cable the kit 20 / Antenna service kit (ipm 12) Cable between main board and alarm lamp board / Main board PCBA / Cable between main board and keypad board / 24 / Inner hexagon screw, M3 6 / / Signal cable for 12" screen / Cable between the main board and backlight board (12") / Industrial SD card (SLC), 1G / 8-31

114 8.4.4 Rear Housing Assembly Exploded View Parts List SN PN Description FRU part number Remarks Only for ipm 12; The color of both the front panel and rear panel has been changed. Color difference may result if either is / Rear housing assembly (ipm 12) replaced separately. / Rear housing assembly (ipm 7) Only for ipm 7 2 / Speaker pad / / Speaker, 2W, 4ohm, 500 Hz / Interface converter board (ipm 10, full config, USB) 2 different configuration Interface converter board (ipm 10) / Speaker pad / / 6 / Screw, Pan head with washer, Phillips M3 6 / / Power management and interface board (full config, USB) different configuration Power management and interface board / Power board PCBA (ipm 12) / / 9 / Battery compartment subassembly (12 inch) / / 10 / Parameter board bracket (ipm 12) / / 8-32

115 SN PN Description FRU part number Remarks 11 / I/O interface waterproof pad (ipm 10) / / 12 / Screw, pan head, Phillips, M3 6 / / AC Inlet Hook / 14 Cable between power management board and I/O interface board / 15 Cable between the interface board and main board / 16 Cable between the power management board and parameter board / Recorder cable / 18 / Fixing strip, CHS mm / / USB plug / 20 / Battery door assembly service kit (ipm 12) / Battery Compartment Assembly Exploded View Parts List SN PN Description FRU part number Remarks 1 / Battery compartment (ipm 12) / / 2 / Battery latch (ipm 12) / / Knob, Battery latch / 8-33

116 SN PN Description FRU part number Remarks 4 / Batteyr spring (ipm 12) / / 5 / Screw, Pan head with washer, Phillips M3 6 / / 6 / Spring, EMI / / 7 / M4 8 combined screw / / 8 / Battery connector board assembly (ipm 12) / Multi-parameter Assembly For the exploded view and parts list of the multi-parameter assembly, refer to Section Multi-parameter Assembly NIBP Pump and Valve Kit For the exploded view and parts list of the NIBP pump and valve kit, refer to Section NIBP Pump and Valve Kit IBP_C.O. Module Assembly For the exploded view and parts list of the IBP_C.O. module assembly, refer to Section IBP_C.O. Module Assembly IBP_C.O._Sidestream CO 2 Module Assembly/IBP_Sidestream CO 2 Module Assembly For the exploded view and parts list of the IBP_C.O._Siderstream CO2 module assembly and IBP_Sidestream CO2 module assembly, refer to Section IBP_C.O._Sidestream CO2 Module Assembly/ IBP_Sidestream CO2 Module Assembly IBP_C.O._Microstream CO 2 Module Assembly/IBP_Microstream CO 2 Module Assembly For the exploded view and parts list of the IBP_C.O._Microstream CO2 module assembly and IBP_Microstream CO2 module assembly, refer to Section IBP_C.O._Microstream CO2 Module Assembly/IBP_Microstream CO2 Module Assembly IBP_C.O._Mainstream CO 2 Module Assembly/IBP_Mainstream CO 2 Module Assembly For the exploded view and parts list of the IBP_C.O._Mainstream CO2 module assembly and IBP_Mainstream CO2 Module Assembly, refer to Section IBP_C.O._Mainstream CO2 Module Assembly/IBP_Mainstream CO2 Module Assembly IBP_C.O._AG Module Assembly/IBP_AG Module Assembly For the exploded view and parts list of the IBP_C.O._AG module assembly and IBP_AG Module Assembly, refer to Section IBP_C.O._AG Module Assembly/ IBP_AG Module Assembly. 8-34

117 A Electrical Safety Inspection The following electrical safety tests are recommended as part of a comprehensive preventive maintenance program. They are a proven means of detecting abnormalities that, if undetected, could prove dangerous to either the patient or the operator. Additional tests may be required according to local regulations. All tests can be performed using commercially available safety analyzer test equipment. These procedures assume the use of a 601PROXL International Safety Analyzer or equivalent safety analyzer. Other popular testers complying with IEC used in Europe, such as Fluke, Metron, or Gerb, may require modifications to the procedure. Please follow the instructions of the analyzer manufacturer. The consistent use of a safety analyzer as a routine step in closing a repair or upgrade is emphasized as a mandatory step if an approved agency status is to be maintained. The safety analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line voltage and grounding, as well as total current loads. A.1 Power Cord Plug Test Item The power plug pins The power The plug body plug The strain relief The power plug The power cord Acceptance Criteria No broken or bent pin. No discolored pins. No physical damage to the plug body. No physical damage to the strain relief. No plug warmth for device in use. No loose connections. No physical damage to the cord. No deterioration to the cord. For devices with detachable power cords, inspect the connection at the device. For devices with non-detachable power cords, inspect the strain relief at the device. A.2 Device Enclosure and Accessories A.2.1 Visual Inspection Test Item The enclosure and accessories Acceptance Criteria No physical damage to the enclosure and accessories. No physical damage to meters, switches, connectors, etc. No residue of fluid spillage (e.g., water, coffee, chemicals, etc.). No loose or missing parts (e.g., knobs, dials, terminals, etc.). A.2.2 Contextual Inspection Test Item Acceptance Criteria No unusual noises (e.g., a rattle inside the case). The enclosure and accessories No unusual smells (e.g., burning or smoky smells, particularly from ventilation holes). No taped notes that may suggest device deficiencies or operator concerns. A-1

118 A.3 Device Labeling Check the labels provided by the manufacturer or the healthcare facility are present and legible. Main unit label Integrated warning labels A.4 Protective Earth Resistance Protective Earth Resistance is measured using the RED test lead attached to the DUT Protective Earth terminal or enclosure. Select the test current (25 amp) by pressing SOFT KEY 3. The front panel outlet power is turned off for this test. The following conditions apply: L1 and L2 Open. Preparation 1. First select the test current that will be used for performing the Protective Earth Resistance test by pressing AMPERES (SOFT KEY 3). 2. Connect the test lead(s) between the RED input jack and the GREEN input jack. 3. Press CAL LEADS. The 601PRO will measure the lead resistance, and if less than Ohms, it will store the reading and subtract it from all earth resistance readings taken at the calibrated current. If the calibration fails, the previously stored readings will be used until a passing calibration has occurred. WARNING During Earth Resistance testing, the DUT must be plugged into the 601PRO front outlet. If the DUT fails Earth Resistance, discontinue tests and label the device defective. To Perform the Test 1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet. 2. Attach the 601PRO RED input lead to the device s Protective Earth terminal or an exposed metal area. 3. Press shortcut key 3. The Protective Earth Resistance test is displayed. 4. Press SOFT KEY 3 to select a test current (25 amp). The selected test current is displayed in the upper right corner of the display. A-2

119 5. Press START TEST to start the test. The test current is applied while resistance and current readings are taken. This takes approximately 5 seconds. 6. Press the print data key at any time to generate a printout of the latest measurement(s). NOTE When "Over" is displayed for Ohms, this signifies that a valid measurement was not obtained because either an open connection was detected or that the measurement was not within range. Readings greater than Ohms will be displayed as Over. In Case of Failure Once it reaches the limitation, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS ALL COUNTRIES R = 0.2 Ω Maximum A.5 Earth Leakage Test Run an Earth Leakage test on the device being tested before performing any other leakage tests. Leakage current is measured the following ways: Earth Leakage Current, leakage current measured through DUT outlet Earth Earth Leakage Current AP-EARTH (ALL Applied Parts connected to Earth), leakage current measured through DUT outlet Earth There is no need to attach a test lead; the 601PRO automatically connects the measuring device internally. To Perform the Test 1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2. Attach the device's applied parts to the 601PRO applied part terminals if applicable. 3. Press shortcut key 4.The Earth Leakage test appears on the display, and the test begins immediately: A-3

120 SOFT KEY 1 toggles the DUT outlet Polarity from Normal to Off to Reverse. SOFT KEY 2 toggles the DUT outlet from Earth to No Earth. SOFT KEY 3 toggles the DUT outlet from L2 to No L2. SOFT KEY 4 toggles the AP to Earth to No AP to Earth. 4. Press the print data key at any time to generate a printout of the latest measurement. In Case of Failure Check any broken of the enclosure. Replace any defective part. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS For UL , 300 μa in Normal Condition 1000 μa in Single Fault Condition For IEC , 500 μa in Normal Condition 1000 μa in Single Fault Condition A.6 Patient Leakage Current Patient leakage currents are measured between a selected applied part and mains earth. All measurements have a true RMS only response. A-4

121 Preparation Perform a calibration from the Mains on Applied Part menu. The following outlet conditions apply when performing this test: Normal Polarity, Earth Open, Outlet ON Normal Polarity, Outlet ON Normal Polarity, L2 Open, Outlet ON Reversed Polarity, Outlet ON Reversed Polarity, Earth Open, Outlet ON Reversed Polarity, L2 Open, Outlet ON WARNING If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only. To Perform the Test 1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2. Attach the applied parts to the 601PRO's applied part terminals. 3. Press shortcut key 6. The Patient Leakage test is displayed, and the test begins immediately. 4. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current. 5. Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO. 6. Press the print data key at any time to generate a printout of the latest measurement. In Case of Failure Check any broken of the enclosure. Replace any defective part. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. A-5

122 LIMITS For CF For BF applied parts 10μA in Normal Condition 50μA in Single Fault Condition applied parts 100μA in Normal Condition 500μA in Single Fault Condition A.7 Mains on Applied Part Leakage The Mains on Applied Part test applies a test voltage, which is 110% of the mains voltage, through a limiting resistance, to selected applied part terminals. Current measurements are then taken between the selected applied part and earth. Measurements are taken with the test voltage (110% of mains) to applied parts in the normal and reverse polarity conditions as indicated on the display. The following outlet conditions apply when performing the Mains on Applied Part test. Normal Polarity; Reversed Polarity Preparation To perform a calibration from the Mains on Applied Part test, press CAL (SOFT KEY 2). 1. Disconnect ALL patient leads, test leads, and DUT outlet connections. 2. Press CAL to begin calibration, as shown: If the calibration fails, the previously stored readings will be used until a passing the esc/stop key has no effect during calibration. calibration has occurred. Also, 3. When the calibration is finished, the Mains on Applied Part test will reappear. WARNING A 2-beep-per-second signal indicates high voltage present at the applied part terminals while a calibration is being performed. High voltage is present at applied part terminals while measurements are being taken. A-6

123 To Perform the Test 1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the Attach the applied parts to the 601PRO applied part terminals. 3. Attach the red terminal lead to a conductive part on the DUT enclosure. 4. Press shortcut key 7. The Mains on Applied Part test is displayed. 5. Select the desired outlet configuration and applied part to test using the appropriate SOFT KEYS: 6. Press START TEST (SOFT KEY 1) to begin the test. 7. Press the print data key to generate a printout of the latest measurement. NOTE If all of the applied parts correspond to the instrument type, the applied parts will be tied together and one reading will be taken. If any of the applied parts differ from the instrument type, all applied parts will be tested individually, based on the type of applied part. This applies to Auto and Step modes only. In Case of Failure Check any broken of the enclosure. Replace any defective part. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS For CF applied parts: 50 μa For BF applied parts: 5000 μa A-7

124 A.8 Patient Auxiliary Current Patient Auxiliary currents are measured between any selected ECG jack and the remaining selected ECG jacks. All measurements may have a true RMS only response. Preparation 1. From the MAIN MENU, or with the outlet unpowered, plug the DUT into the 601PRO front panel outlet, and turn on the device. 2. Attach the patient leads to the 601PRO ECG jacks. 3. Define the Lead Types from the View Settings Option (refer to: Lead Type Definitions in Section 5 of this chapter). 4. Press shortcut key 8. The Patient Auxiliary Current test is displayed, and the test begins immediately. Display values are continuously updated until another test is selected. 5. Press SOFT KEYS 1-4 to select leakage tests 6. Press APPLIED PART (SOFT KEY 4) at any time to select the desired applied part leakage current: 7. Modify the configuration of the front panel outlet by pressing the appropriate SOFT KEY on the 601PRO: 8. Press the print data key at any time to generate a printout of the latest measurement. In Case of Failure Check any broken of the enclosure. Replace any defective part. Inspect wiring for bad crimps, poor connections, or damage. Test the wall outlet; verify it is grounded and is free of other wiring abnormalities. Notify the user or owner to correct any deviations. As a work around, check the other outlets to see if they could be used instead. Change another probe to confirm if the fail is caused by console. If the leakage current measurement tests fail on a new unit and if situation can not be corrected, submit a Safety Failure Report to document the system problem. Remove unit from operation. If all else fails, stop using and inform the Customer Service Engineer for analysis and disposal. LIMITS For CF For BF applied parts, 10μA in Normal Condition 50μA in Single Fault Condition applied parts, 100μA in Normal Condition 500μA in Single Fault Condition A-8